We support the development and registration of your medical devices, such as class I to class III devices, including software, in vitro diagnostic and drug-device combination products. We can also help you setting up an ISO compliant quality management system. We do this both efficiently and with respect to time and cost.
The four pillars of our approach are to keep the helicopter view, to look for potential opportunities, communicate risks, and to find the optimal solution for issues at hand. This enables our clients to maintain good relationships with notified bodies and agencies worldwide.
When you tell us about your goals, we will challenge you and discuss with you whether your product is considered to be a medical device in order to provide you the best and efficient support to achieve your goals. When the exact scope and budget for the project is clear, we'll dive into the details.
Services we are able to provide are:
- Qualify and classify your medical device against the applicable regulation
- Advise on global market access, the optimal regulatory strategy and execute this strategy in line with the chosen route of conformity
- Select assessment agencies such as Notified Bodies and establish a professional relationship with them
- Convert your EU registration files to EU MDR compliant technical documentation
- Help you to understand your role and other roles, such as that of the Person Responsible for Regulatory Compliance (PRRC)
- Services during the design and development phase of the medical device
- Advise on specifications and user test requirements
- Perform general safety and performance requirements check
- Author and/or review verification and validation protocols
- Execute verification and validation of product performance
- Author and/or review Technical Documentation
- Facilitate notification to agencies and assessment by notified bodies
- Services during the marketing phase of the medical device
- Support appropriate change management when re-designing the medical device
- Perform compliance check on the company's quality management system
- Perform ISO/IEC compliance check; compliance with ISO 13485, ISO 14971, ISO 14155, IEC 62304, IEC 62366, etc.
- Perform periodic risk assessments and clinical evaluations
- Support management with periodic management reviews and annual product reviews (including PSUR)
- Advise on how to prepare for on-site inspections by agencies and support your company during the actual inspection
- Support with regulatory intelligence