Our Services - Medical Devices and Combination Products
We provide regulatory and quality support during development, registration and/or maintenance of medical devices (all risk classes, incl. software and IVDs) and drug-device combination products.
We provide assessments on medical device qualification, classification, technical file support and review, submission support and registration (e.g. local agencies, Notified Bodies, EMA, etc). We can advise on the best routes of conformity and will offer pragmatic solutions for regulatory services over the life-cycle of your products. We will liaise with Notified Bodies and agencies when needed and prepare you for certification and surveillance audits. We can support you in setting up or maintaining a Quality Management System based on requirements of 21CFR 210/211 and 820, Eudralex, ISO 14971, ISO 13485, 9001 and MDD 93/42/EEC, or guide you in other questions to bring you to that next level.
If your challenge is to keep up to date with new Regulatory Information, like new and upcoming updates to standards, regulations, directives and guidance documents, then we will support you with obtaining them, interpreting them and closing any compliance gaps coming from them.
Services in detail:
- Qualification and Classification of all types of medical devices (incl software and IVDs) according to applicable regulations (EU, US, Canada, etc)
- Regulatory strategy advice and execution (e.g. choice of Route of conformity; Labeling requirements)
- Design and Development regulatory support
o Requirements/Specification review
o Verification/Validation requirements
o ((pre-)Clinical) Protocol support/review/writing
o User test requirements
o Technical File support/review/writing
o Essential Requirements check
o Notification to / Registration with agencies
- Medical Device Life-cycle support
o Compliance check on QMS and Safety procedures
o ISO/IEC compliance (e.g. 14155, 13485, 14971)
o Change Management support
o FMEA/Risk management/Clinical evaluation (periodic) requirements
o Management Review / Annual product review / Agency (pre)inspection support
- Qualified Regulatory Expert Role
o Project Plan, Risk Management Plan, Clinical Evaluation Plan
o ER checklist
o Regulatory (pre)audit
- Be your EU Authorized Representative
- Notification of upcoming and/or new regulations, directives, guidance and standards (e.g. ISO/IEC) relevant to your products, including gap analysis for your technical file, your quality management system (SOPs, WI), annual and third party agreements.