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Has organizational leadership approved of the product security policy and procedures? Does the system follow industry standard encryption practices to secure connections? Does the system enforce secure credential creation, usage and maintenance principles?
Medical Devices
Organizational leadership must approve product security policy and procedures for medical devices to ensure patient safety and regulatory compliance.
1. Implement mandatory training on product security measures to ensure compliance. (Benefits: Ensures organizational buy-in and understanding of product security policies and procedures. )
2. Conduct regular audits and risk assessments to identify potential vulnerabilities. (Benefits: Proactively manage risks and prevent potential security breaches. )
3. Establish a robust incident response plan to address any security incidents that may occur. (Benefits: Allows for quick and effective response to security incidents, minimizing potential damage. )
4. Utilize secure coding practices and perform regular code reviews to ensure product security. (Benefits: Minimizes the likelihood of security issues in the product′s code. )
5. Implement encryption protocols to safeguard sensitive data in the product. (Benefits: Protects sensitive information from unauthorized access. )
6. Develop a product security lifecycle management process to ensure ongoing security efforts. (Benefits: Ensures continued focus on product security throughout its lifespan. )
7. Partner with third-party security experts for independent assessments and validations. (Benefits: Provides an external validation of product security and identifies any potential gaps. )
8. Update and patch the product regularly to address any known vulnerabilities. (Benefits: Keeps the product up-to-date with the latest security measures. )
9. Establish clear roles and responsibilities for product security within the organization. (Benefits: Ensures accountability and clear communication for addressing security concerns. )
10. Continuously monitor and assess the product′s security posture to identify and address any emerging threats. (Benefits: Proactively identify and mitigate any potential security risks. )
CONTROL QUESTION: Has organizational leadership approved of the product security policy and procedures?
Big Hairy Audacious Goal (BHAG) for 10 years from now:
Our goal for 10 years from now is to be the leader in product security for medical devices, ensuring the safety and privacy of patients and healthcare providers worldwide. We aim to have all of our products adhere to the most stringent security standards, with regular updates and improvements as technology evolves.
Organizational leadership will have not only approved, but actively championed our product security policy and procedures, recognizing the critical importance of protecting sensitive patient data and maintaining trust in our brand. Our policies and procedures will be comprehensive, regularly reviewed and updated, and integrated into every stage of the product development process.
Through strategic partnerships and collaborations with top cybersecurity experts and regulatory bodies, we will continuously stay ahead of any potential threats and ensure the highest level of security for our medical devices.
Furthermore, we will actively educate and train our employees on the importance of product security and their role in upholding our company′s standards. Our ultimate goal is to set the industry standard for medical device security and be a trusted and reliable partner for healthcare organizations around the world. By achieving this, we will not only contribute to the betterment of patient care, but also solidify our position as a leader in the medical device industry.
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Client Situation:
Medical Devices is a leading manufacturer of medical equipment and devices used in hospitals and healthcare facilities. The company has been in operation for over 20 years and has established a strong reputation in the market for its reliable and high-quality products. However, with the increasing threat of cybersecurity breaches, the company recognized the need to implement a robust product security policy and procedures to ensure the safety and integrity of its devices.
In the past, Medical Devices had not placed much emphasis on cybersecurity as most of their products were standalone devices with limited connectivity. However, with the rise of connected medical devices and the growing number of cyberattacks targeting healthcare organizations, the company realized the importance of incorporating cybersecurity into their product development process.
The CEO and top-level management identified this as a critical issue that required immediate attention and approved the implementation of a product security policy and procedures. The leadership team understood that investing in cybersecurity measures would not only safeguard their products but also protect their customers and maintain their reputation in the industry.
Consulting Methodology:
The consulting team from Cybersecurity Solutions Inc. was engaged to assist Medical Devices in designing and implementing a comprehensive product security policy and procedures. The methodology used by the consulting team included the following steps:
1. Assessment: The first step was to conduct a thorough assessment of the current state of cybersecurity at Medical Devices. This involved reviewing existing policies and procedures, conducting interviews with key stakeholders, and identifying areas of vulnerability.
2. Gap Analysis: Based on the assessment, the consulting team conducted a gap analysis to identify any deficiencies in the current security measures and compare them to industry best practices and regulatory requirements.
3. Policy Development: Once the gaps were identified, the next step was to develop a product security policy that met the specific needs of Medical Devices. This involved creating a framework for managing cybersecurity risks, defining roles and responsibilities, and establishing guidelines for incident response and reporting.
4. Procedure Implementation: The consulting team worked closely with the cross-functional teams at Medical Devices to implement the recommended procedures. This involved training employees on the new policies, conducting vulnerability scans, and implementing security controls.
5. Testing and Validation: To ensure the effectiveness of the new policy and procedures, the consulting team conducted testing and validation exercises, including penetration testing, to identify any weaknesses and verify that the system was adequately protected.
Deliverables:
The consulting team provided the following deliverables as part of the engagement:
1. Product Security Policy Document: A comprehensive policy document outlining the framework and guidelines for managing product security at Medical Devices.
2. Procedures Manual: Detailed procedures for implementing the policy, including incident response procedures, secure coding practices, and vulnerability management processes.
3. Training Materials: Training materials for employees on the new policies and procedures.
4. Compliance Report: A report detailing the organization′s compliance with industry best practices and regulatory requirements.
Implementation Challenges:
The implementation of the product security policy and procedures was not without challenges. The following were some of the key challenges faced by the consulting team during the engagement:
1. Lack of Awareness: Many employees at Medical Devices were not aware of the potential cybersecurity risks or the importance of implementing security measures. Hence, the consulting team had to conduct extensive training to educate employees.
2. Resistance to Change: Some employees were resistant to changes in their daily workflow to accommodate the new procedures. The consulting team had to work closely with department heads to address their concerns and ensure smooth implementation.
3. Legacy Systems: Medical Devices had a few legacy systems that were not designed with security in mind. The consulting team had to work with the IT team to implement additional security controls to protect these systems.
KPIs:
The success of the engagement was measured using the following key performance indicators (KPIs):
1. Number of Cybersecurity Incidents: The number of cybersecurity incidents reported after the implementation of the new policies and procedures.
2. Compliance with Industry Standards: The organization′s compliance with industry best practices and regulatory requirements, as measured through audits and assessments.
3. Employee Training Completion: The number of employees who have completed the training on the new policies and procedures.
4. Time to Contain Incidents: The time taken to identify and contain any cybersecurity incidents.
Management Considerations:
The successful implementation of the product security policy and procedures at Medical Devices required the support and involvement of senior management. The CEO and top-level management played a crucial role in approving and sponsoring the project. They also provided the necessary resources and support to ensure its successful implementation.
Additionally, the consulting team conducted regular progress updates and presentations to keep the management informed and engaged throughout the engagement. This helped in addressing any concerns or questions raised by the leadership team and ensured their buy-in.
Conclusion:
In conclusion, the engagement with Cybersecurity Solutions Inc. was instrumental in helping Medical Devices implement a robust product security policy and procedures. The consulting methodology utilized was effective in identifying gaps and providing practical solutions to address them. The management′s commitment, along with the dedication and expertise of the consulting team, resulted in a successful implementation that has enhanced the cybersecurity posture of Medical Devices.
Our Knowledge Base offers everything you need in one comprehensive package.
Our Medical Devices and Regulatory Information Management Knowledge Base consists of 1546 prioritized requirements, solutions, benefits, results, and real-life case studies.
We have done the research for you and compiled the most important questions to ask in order to get results based on urgency and scope.
This means you can save valuable time and energy by having all the information you need at your fingertips.
Compared to our competitors and alternatives, our dataset is unparalleled in its breadth and depth of information.
Our product is designed specifically for professionals in the medical devices industry and covers a diverse range of product types.
Whether you are a seasoned pro or just starting out, our Knowledge Base is your go-to resource for all things Medical Devices and Regulatory Information Management.
Using this dataset is easy, with a user-friendly interface that allows you to quickly find the information you need.
And best of all, it is an affordable DIY alternative to expensive consulting services.
You no longer have to worry about the high costs associated with getting the information and insights you need to excel in this field.
Our Knowledge Base contains a detailed overview of products and specifications, making it easy to compare and understand the differences between different product types.
It also includes information on how Medical Devices and Regulatory Information Management relates to other industries, giving you a well-rounded understanding of the topic.
Investing in our Medical Devices and Regulatory Information Management Knowledge Base comes with numerous benefits for your business.
Stay ahead of the competition by having access to the latest and most relevant information.
Increase efficiency and productivity by having all the necessary knowledge in one convenient location.
And make informed decisions that can positively impact your bottom line.
Don′t just take our word for it, our Knowledge Base is backed by thorough research and proven results.
It is a valuable resource for businesses of all sizes, from startups to established companies.
With our affordable cost, you can get access to all this information without breaking the bank.
In summary, our Medical Devices and Regulatory Information Management Knowledge Base is the ultimate tool for professionals in the industry.
It offers unparalleled depth and breadth of information, user-friendly interface, and affordability.
Upgrade your knowledge and drive results for your business with our comprehensive dataset.
Don′t wait, get your copy now and see the difference it can make for yourself!
Discover Insights, Make Informed Decisions, and Stay Ahead of the Curve:
Key Features:
Comprehensive set of 1546 prioritized Medical Devices requirements. - Extensive coverage of 184 Medical Devices topic scopes.
- In-depth analysis of 184 Medical Devices step-by-step solutions, benefits, BHAGs.
- Detailed examination of 184 Medical Devices case studies and use cases.
- Digital download upon purchase.
- Enjoy lifetime document updates included with your purchase.
- Benefit from a fully editable and customizable Excel format.
- Trusted and utilized by over 10,000 organizations.
- Covering: Regulatory Documentation, Device Classification, Management Systems, Risk Reduction, Recordkeeping Requirements, Market Conduct, Regulatory Frameworks, Financial Reporting, Legislative Actions, Device Labeling, Testing Procedures, Audit Management, Regulatory Compliance Risk Management, Taxation System, ISO 22361, Regulatory Reporting, Regulatory Intelligence, Production Records, Regulatory Efficiency, Regulatory Updates, Security Incident Handling Procedure, Data Security, Regulatory Workflows, Change Management, Pharmaceutical Industry, Training And Education, Employee File Management, Regulatory Information Management, Data Integrity, Systems Review, Data Mapping, Rulemaking Process, Web Reputation Management, Organization Restructuring, Decision Support, Data Retention, Regulatory Compliance, Outsourcing Management, Data Consistency, Enterprise Risk Management for Banks, License Verification, Supply Chain Management, External Stakeholder Engagement, Packaging Materials, Inventory Management, Data Exchange, Regulatory Policies, Device Registration, Adverse Event Reporting, Market Surveillance, Legal Risks, User Acceptance Testing, Advertising And Promotion, Cybersecurity Controls, Application Development, Quality Assurance, Change Approval Board, International Standards, Business Process Redesign, Operational Excellence Strategy, Vendor Management, Validation Reports, Interface Requirements Management, Enterprise Information Security Architecture, Retired Systems, Quality Systems, Information Security Risk Management, IT Systems, Ensuring Safety, Quality Control, ISO 22313, Compliance Regulatory Standards, Promotional Materials, Compliance Audits, Parts Information, Risk Management, Internal Controls Management, Regulatory Changes, Regulatory Non Compliance, Forms Management, Unauthorized Access, GCP Compliance, Customer Due Diligence, Optimized Processes, Electronic Signatures, Supply Chain Compliance, Regulatory Affairs, Standard Operating Procedures, Product Registration, Workflow Management, Medical Coding, Audit Trails, Information Technology, Response Time, Information Requirements, Utilities Management, File Naming Conventions, Risk Assessment, Document Control, Regulatory Training, Master Validation Plan, Adverse Effects Monitoring, Inventory Visibility, Supplier Compliance, Ensuring Access, Service Level Targets, Batch Records, Label Artwork, Compliance Improvement, Master Data Management Challenges, Good Manufacturing Practices, Worker Management, Information Systems, Data Standardization, Regulatory Compliance Reporting, Data Privacy, Medical diagnosis, Regulatory Agencies, Legal Framework, FDA Regulations, Database Management System, Technology Strategies, Medical Record Management, Regulatory Analysis, Regulatory Compliance Software, Labeling Requirements, Proof Of Concept, FISMA, Data Validation, MDSAP, IT Staffing, Quality Metrics, Regulatory Tracking, Data Analytics, Validation Protocol, Compliance Implementation, Government Regulations, Compliance Management, Drug Delivery, Master Data Management, Input Devices, Environmental Impact, Business Continuity, Business Intelligence, Entrust Solutions, Healthcare Reform, Strategic Objectives, Licensing Agreements, ISO Standards, Packaging And Labeling, Electronic Records, Electronic Databases, Operational Risk Management, Stability Studies, Product Tracking, Operational Processes, Regulatory Guidelines, Output Devices, Safety Reporting, Information Governance, Data Management, Third Party Risk Management, Data Governance, Securities Regulation, Document Management System, Import Export Regulations, Electronic Medical Records, continuing operations, Drug Safety, Change Control Process, Security incident prevention, Alternate Work Locations, Connected Medical Devices, Medical Devices, Privacy Policy, Clinical Data Management Process, Regulatory Impact, Data Migration, Collections Data Management, Global Regulations, Control System Engineering, Data Extraction, Accounting Standards, Inspection Readiness
Medical Devices Assessment Dataset - Utilization, Solutions, Advantages, BHAG (Big Hairy Audacious Goal):
Medical Devices
Organizational leadership must approve product security policy and procedures for medical devices to ensure patient safety and regulatory compliance.
1. Implement mandatory training on product security measures to ensure compliance. (Benefits: Ensures organizational buy-in and understanding of product security policies and procedures. )
2. Conduct regular audits and risk assessments to identify potential vulnerabilities. (Benefits: Proactively manage risks and prevent potential security breaches. )
3. Establish a robust incident response plan to address any security incidents that may occur. (Benefits: Allows for quick and effective response to security incidents, minimizing potential damage. )
4. Utilize secure coding practices and perform regular code reviews to ensure product security. (Benefits: Minimizes the likelihood of security issues in the product′s code. )
5. Implement encryption protocols to safeguard sensitive data in the product. (Benefits: Protects sensitive information from unauthorized access. )
6. Develop a product security lifecycle management process to ensure ongoing security efforts. (Benefits: Ensures continued focus on product security throughout its lifespan. )
7. Partner with third-party security experts for independent assessments and validations. (Benefits: Provides an external validation of product security and identifies any potential gaps. )
8. Update and patch the product regularly to address any known vulnerabilities. (Benefits: Keeps the product up-to-date with the latest security measures. )
9. Establish clear roles and responsibilities for product security within the organization. (Benefits: Ensures accountability and clear communication for addressing security concerns. )
10. Continuously monitor and assess the product′s security posture to identify and address any emerging threats. (Benefits: Proactively identify and mitigate any potential security risks. )
CONTROL QUESTION: Has organizational leadership approved of the product security policy and procedures?
Big Hairy Audacious Goal (BHAG) for 10 years from now:
Our goal for 10 years from now is to be the leader in product security for medical devices, ensuring the safety and privacy of patients and healthcare providers worldwide. We aim to have all of our products adhere to the most stringent security standards, with regular updates and improvements as technology evolves.
Organizational leadership will have not only approved, but actively championed our product security policy and procedures, recognizing the critical importance of protecting sensitive patient data and maintaining trust in our brand. Our policies and procedures will be comprehensive, regularly reviewed and updated, and integrated into every stage of the product development process.
Through strategic partnerships and collaborations with top cybersecurity experts and regulatory bodies, we will continuously stay ahead of any potential threats and ensure the highest level of security for our medical devices.
Furthermore, we will actively educate and train our employees on the importance of product security and their role in upholding our company′s standards. Our ultimate goal is to set the industry standard for medical device security and be a trusted and reliable partner for healthcare organizations around the world. By achieving this, we will not only contribute to the betterment of patient care, but also solidify our position as a leader in the medical device industry.
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Medical Devices Case Study/Use Case example - How to use:
Client Situation:
Medical Devices is a leading manufacturer of medical equipment and devices used in hospitals and healthcare facilities. The company has been in operation for over 20 years and has established a strong reputation in the market for its reliable and high-quality products. However, with the increasing threat of cybersecurity breaches, the company recognized the need to implement a robust product security policy and procedures to ensure the safety and integrity of its devices.
In the past, Medical Devices had not placed much emphasis on cybersecurity as most of their products were standalone devices with limited connectivity. However, with the rise of connected medical devices and the growing number of cyberattacks targeting healthcare organizations, the company realized the importance of incorporating cybersecurity into their product development process.
The CEO and top-level management identified this as a critical issue that required immediate attention and approved the implementation of a product security policy and procedures. The leadership team understood that investing in cybersecurity measures would not only safeguard their products but also protect their customers and maintain their reputation in the industry.
Consulting Methodology:
The consulting team from Cybersecurity Solutions Inc. was engaged to assist Medical Devices in designing and implementing a comprehensive product security policy and procedures. The methodology used by the consulting team included the following steps:
1. Assessment: The first step was to conduct a thorough assessment of the current state of cybersecurity at Medical Devices. This involved reviewing existing policies and procedures, conducting interviews with key stakeholders, and identifying areas of vulnerability.
2. Gap Analysis: Based on the assessment, the consulting team conducted a gap analysis to identify any deficiencies in the current security measures and compare them to industry best practices and regulatory requirements.
3. Policy Development: Once the gaps were identified, the next step was to develop a product security policy that met the specific needs of Medical Devices. This involved creating a framework for managing cybersecurity risks, defining roles and responsibilities, and establishing guidelines for incident response and reporting.
4. Procedure Implementation: The consulting team worked closely with the cross-functional teams at Medical Devices to implement the recommended procedures. This involved training employees on the new policies, conducting vulnerability scans, and implementing security controls.
5. Testing and Validation: To ensure the effectiveness of the new policy and procedures, the consulting team conducted testing and validation exercises, including penetration testing, to identify any weaknesses and verify that the system was adequately protected.
Deliverables:
The consulting team provided the following deliverables as part of the engagement:
1. Product Security Policy Document: A comprehensive policy document outlining the framework and guidelines for managing product security at Medical Devices.
2. Procedures Manual: Detailed procedures for implementing the policy, including incident response procedures, secure coding practices, and vulnerability management processes.
3. Training Materials: Training materials for employees on the new policies and procedures.
4. Compliance Report: A report detailing the organization′s compliance with industry best practices and regulatory requirements.
Implementation Challenges:
The implementation of the product security policy and procedures was not without challenges. The following were some of the key challenges faced by the consulting team during the engagement:
1. Lack of Awareness: Many employees at Medical Devices were not aware of the potential cybersecurity risks or the importance of implementing security measures. Hence, the consulting team had to conduct extensive training to educate employees.
2. Resistance to Change: Some employees were resistant to changes in their daily workflow to accommodate the new procedures. The consulting team had to work closely with department heads to address their concerns and ensure smooth implementation.
3. Legacy Systems: Medical Devices had a few legacy systems that were not designed with security in mind. The consulting team had to work with the IT team to implement additional security controls to protect these systems.
KPIs:
The success of the engagement was measured using the following key performance indicators (KPIs):
1. Number of Cybersecurity Incidents: The number of cybersecurity incidents reported after the implementation of the new policies and procedures.
2. Compliance with Industry Standards: The organization′s compliance with industry best practices and regulatory requirements, as measured through audits and assessments.
3. Employee Training Completion: The number of employees who have completed the training on the new policies and procedures.
4. Time to Contain Incidents: The time taken to identify and contain any cybersecurity incidents.
Management Considerations:
The successful implementation of the product security policy and procedures at Medical Devices required the support and involvement of senior management. The CEO and top-level management played a crucial role in approving and sponsoring the project. They also provided the necessary resources and support to ensure its successful implementation.
Additionally, the consulting team conducted regular progress updates and presentations to keep the management informed and engaged throughout the engagement. This helped in addressing any concerns or questions raised by the leadership team and ensured their buy-in.
Conclusion:
In conclusion, the engagement with Cybersecurity Solutions Inc. was instrumental in helping Medical Devices implement a robust product security policy and procedures. The consulting methodology utilized was effective in identifying gaps and providing practical solutions to address them. The management′s commitment, along with the dedication and expertise of the consulting team, resulted in a successful implementation that has enhanced the cybersecurity posture of Medical Devices.
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