QUALITY SERVICES
The most important element of getting your medical device released /cleared is the implementation of a quality management system in compliance with the global requirements.
QUALITY STRATEGY AND QUALITY CONSULTING SERVICES
A sound quality management system in compliance with the (inter)national requirements will provide your company a structured method for your processes and aid in obtaining your certifications.
Thinking about expanding your business on a global scale, incorporation of an extended quality system including a wider range of compliance above just the local requirement might seem an additional burden at first but will result in an experienced workforce already working at a higher compliance level and as such are prepared for future challenges.
Quality Strategy
Quality strategy is depending on the market you would like to enter and to the regional requirements. A custom-made service package will be set-up for implementing, certifying and maintaining a quality management system suitable for the medical device industry and applicable global regulation.
MedQ Consultants B.V. can support you in:
- Quality strategy for the European and other global markets
- Selection of Notified Body
- Implementation and certification of the quality system
- Outsourced or subcontracted processes
Quality consulting services
The most important element of getting your medical device released /cleared is the implementation of a quality management system in compliance with the global requirements.
Our quality service provides support to implement or enhance your quality management system for compliance with applicable regulatory requirements based on your global strategy and market approval requirements.
MedQ Consultants B.V. can support your quality management system (QMS) with:
- GAP analysis
- QMS development, support, review and/or maintenance according to ISO 13485 (EU), 21 CFR Part 820 (US) and/or other global territories
- Conduct / prepare audits (Internal audit, vendor audit, (pre)assessment audit)
- Prepare / support / attend certification assessment audits by Authorities
- Equipment qualification / validation
- Process validation
- QMS / audit training
- Authority contact
- Being your internal quality person / support