My Services
Focus on safe and effective products
Training
Medical device compliance training, customized for customer’s need about the following topics:
- Electrical Device Development according to 60601
- Electrical Device Development according to IEC 62304 / IEC 82304
- Functional Safety
- Risk Management according to ISO 14971
- Usability according to IEC 62366-1 / IEC 60601-1-6
- Collateral Standards like IEC 60601-1-3
- Particular standards on request.
- MDR Annex I
- Artificial Intelligence (AI) and Machine Learning (ML)
- Software as a Medical Device (SaMD) and Software as a Service (SaaS)
- Euratom compliance
- PMS and PMCF
Product Consultancy
Medical device manufacturers are required to meet a significant number of regulatory requirements to bring their product to market. These regulations are focused on ensuring that the devices are safe to operate in a healthcare setting. The regulations can vary from country by country, I offer consultancy primarily on aligning the quality and maintenance of the medical devices, built from a variety of products (HW & SW), or standalone software’s, supporting documentation, artifacts and guidance that enable the customers to more easily address medical device regulatory requirements and build connected, safe and secure medical devices more quickly and effectively. This includes
- Electrical Device according to 60601
- Electrical Device according to IEC 62304 / IEC 82304
- Risk Management according to ISO 14971
- Usability according to IEC 62366-1 / IEC 60601-1-6
- Collateral Standards like IEC 60601-1-3
- Particular standards on request.
- MDR Annex I
- Artificial Intelligence (AI) and Machine Learning (ML)
- Software as a Medical Device (SaMD) and Software as a Service (SaaS)
- Euratom compliance
- Functional Safety inspection and documentation
- Medical device user interface – UI/Ux design is a crucial part of any product creation, the risk of use error and device recalls can be reduced by a well-designed an intuitive interface
- Medical device safety – cybersecurity considerations to protect patient sensitive data, and requirements such as HIPPA, and GDPR, protection of the device from external threats such as viruses, and worms, and the ability to securely update, or react to issues found post-release
- Machine learning based medical devices
- IoT/Cloud Software for medical devices – use cases like predictive maintenance, firmware updates, remote configurations, equipment diagnostics, and fault monitoring
Compliance
Regulation and compliance requirements for medical devices keep evolving e.g. EU MDR/IVDR requirement mandates conformance to ISO 13485 to implement post-market surveillance. I offer a clear guidance on defining regulatory strategy, user needs, design inputs, requirement traceability matrix. I offer consultancy how to follow the standards for medical device product development that applies to your product. Due to my knowledge on standards and regulation, I offer consultancy on device and software documentation including an overall system approach.
- Electrical Device according to 60601
- Electrical Device according to IEC 62304 / IEC 82304
- Risk Management according to ISO 14971
- Usability according to IEC 62366-1 / IEC 60601-1-6
- Collateral Standards like IEC 60601-1-3
- Particular standards on request.
- MDR Annex I
- Artificial Intelligence (AI) and Machine Learning (ML)
- Software as a Medical Device (SaMD) and Software as a Service (SaaS)
- Euratom compliance
Functional Safety inspection and documentation
Long Term Strategy
As a member of several standards committees, like IEC (International Electrical Commission) and DIN (Deutsches Institut für Normung), I am familiar with upcoming regulations and can assist with long-term strategy to prepare compliance for the products in progress as well as for future development.
Expertise
- Electrical Device according to 60601
- Electrical Device according to IEC 62304 / IEC 82304
- Collateral Standards like IEC 60601-1-3
- Artificial Intelligence (AI) and Machine Learning (ML)
- Software as a Medical Device (SaMD) and Software as a Service (SaaS)
- Euratom compliance
- Functional Safety inspection and documentation
- Membership within SC62A / SC62C WG1 / SNAIG
