Gap Analysis for an existing QMS
We help companies first to identify gaps in their current QMS and then to upgrade it to comply with ISO 13485:2016 requirements.
Setup Standard Operating Processes and Procedures
If all you need is a specific QMS process procedure but you don’t know where to begin or simply don’t have time for it this service is for you.
We help with process validation, by reviewing your manufacturing process and providing advice, including writing a validation protocol, to ensure the process is properly validated and complies with all relevant regulatory requirements.
We also perform software validation for all software tools used by the business.
Having extensive experience with various medical devices, we provide assistance with medical device related risk assessment in compliance with ISO 14971.
We provide separate training for QMS processes for your employees, such us:
- Control of Documents and Records
- Design Control
- Supplier evaluation
- Risk Management for medical devices
- Internal Audit for ISO 13485:2016
- Regulatory requirements for marketing materials
- Change Control
- CAPA (Corrective and Preventive Action)
- Reporting to Regulatory Authorities (Notified Bodies and FDA)
We will customize training activities for your company needs.
For more details please contact us