Your QMS (Quality Management System) is the foundation of your business for design principles and manufacturing protocols. It is important that your device is manufactured efficiently, that it is effective and safe to use, and at the same time satisfying customer expectations and remains compliant with regulatory requirements.
QAEC Limited can help you ensure that your business is compliant and help with the implementation and maintenance of QMS either to ISO 13485, 21 CFR part 820 & MDSAP, Gap Analysis, internal auditing, Management Review, completion of CAPA and FSN through the MHRA.
A robust QMS is your foundation to achieve excellent working practices, to deliver consistent results and underpin the success of your device and your business continuity.
Are you confident that your QMS is not at risk without the review of an expert?
We can help you with:
Contact QAEC Limited to see how we can help you
- A review of your QMS
- Internal and External – auditing for both medical device and In-Vitro Diagnostic products
- Managing both Technical and Product Engineering Quality Teams, including external test Laboratories
- 510k and CE UKCA Marking
- Supplier Development and Supplier Quality Assurance
- Validation Management through Life cycle of new medical device products class I to III
- Complaints and Vigilance
- Developing and planning PMS, PMPF Plans and ensuring PSUR Compliance
- Management Review
- Completion of CAPAs and CAPA management in real time
- Validation, Internal Auditing, GSPR (General Safety and Performance Requirements)
- Validation Management and development of site Master Plan, protocols and procedures.
- 21CFR 820 – FDA Remediation support
- ISO 13485: 2016 QMS – creation, implementation, registration, development, maintenance and transfer
- Transfer of ISO 9001: 2015 to ISO 13485: 2016 Quality Management System
- Consolidation of more than one Quality Management in to one
- Hosting Notified Body audits to achieve accreditation – ISO 9001: 2015, ISO 13485: 2016 and MDSAP (Medical Device Single Audit Programme)
- Transition to MDSAP (Medical Device Single Audit Programme)
- Validation of packaging and labelling requirements surrounding changes, translation, and repackaging, to market the device in the relevant Member State
- CE UKCA Marking