Our Services for the Medical Device Industry
We provide our clients with guidance on regulatory affairs and quality for medical device. We can help with all types of medical device from class I to III, active or non-active MDs, implantable MDs or in vitro diagnostic MDs (IVD). Drawing on our consultants’ expertise and our experience from the pharmaceutical industry, we stand out through an ability to manage projects involving MDs used in combination with medicines.
We help our clients to define and implement regulatory road maps enabling them to prepare for the implementation of the new European regulation on medical device.
ASPE Conseil is able to cater for your requirements as well as stipulations under regulations and standards. You will be assigned a dedicated project manager who will act as your direct contact.
Through partnerships forged with other service companies, we are able to provide an integrated package of services.
- Determination of the medical device’s classification.
- Identification of applicable regulations and standards.
- Identification and implementation of the conformity assessment procedure applicable to your MDs.
- Advice and implementation of a regulatory strategy.
- Drafting of CE marking application dossiers in accordance with the European regulatory requirements in force.
- Drafting or review of the instructions for use and labelling of your devices.
- Implementation of your post-market surveillance strategy.
Risk Management Plan
- Application of a risk management process in accordance with the ISO 14971 standard including a full risk assessment of your medical device’s entire life cycles.
- Our consultants generally perform this service in close consultation with the client.
- Identification of the tests to be performed (chemical, biological, technical, stability, etc.).
- Drafting the biological evaluation report in accordance with ISO 10993.
- Drafting non-clinical evaluation report including analyzing of the results from technical studies and tests (in accordance with applicable horizontal/vertical harmonized standards).
- Devising a clinical strategy.
- Preparation of technical documents for MDs with a view to performing clinical investigations (Investigators’ Brochures, etc.).
- Management/guidance with the process of requesting authorization for clinical investigations (issuing requests for an opinion or authorization from various bodies and tracking responses).
- Drafting clinical evaluation reports (these may be literature-based and/or based on the results of investigations) in accordance with the MEDDEV 2.7.1 rev. 4 guideline.
- Implementation of your post-market clinical follow-up.
- Support in the application of the usability engineering process in accordance with the ISO 62366 standard.
- Coordination with the application of the risk management process.
- Drafting usability engineering reports.
Quality Management System
- Definition of a strategy to set up a QMS (full/partial) to support the MD CE-registration.
- Implementation and maintenance of your QMS in accordance with the ISO 13485 standard in close consultation with your team in order to ensure optimal familiarity with the standard.
- Identification and validation of your processes.
- Writing of the documentation (procedures, instructions, quality manuals, etc.).
- Preparation and assistance during follow-up and certification renewal audits.
- Performing QMS audits.
- Outsourcing of quality activities.
CE Mark Dossier
- Preparation, review or update of your Technical File documentation in accordance with applicable European regulatory requirements (scientific writing, compiling and analyzing technical data).
- Submissions to notified bodies.
- Tracking the CE marking procedure and responding to questions from NBs.
- Drafting of your Post-marketing surveillance report.
Audit & Training
- Performing internal and supplier audits.
- Designing and delivering tailored, practical and relevant training to raise your employees’ awareness or enable them to independently implement various regulations, harmonized standards, and guidelines applicable to the MD sector.
Liaison with the Health Authorities & Notified Bodies
- Representing/assisting manufacturers in their dealings with relevant national/European authorities and notified bodies.
- Preparation of documentation required for Scientific Advice Meetings or Technical Advice.
- Organization of the meetings.
- Attendance of the meeting and preparation of the minutes.