An effectively designed and implemented Quality Management System will not only save you time and money in the long run, but also will optimize your manufacturing efficiency and regulatory compliance. Device QR Services, Inc. specializes in setting up and implementing bullet proof Quality Systems.
We can assist with:
- Performing gap assessment of the current QMS system to the requirements of ISO 13485, FDA QSR and Europe MDR.
- Designing and implementation of the quality system that meets ISO 9001 and ISO 13485 requirements.
- Obtaining ISO certifications.
- Reviewing and/or preparing QA system and related documentation.
- Conducting Quality System, Supplier and Due Diligence audits.
- Developing and maintaining supplier qualification program.
- Incorporating statistical sampling plans (e.g. C=0, ANSI Z1.4)
- Developing and implementation of the effective CAPA, internal non-conformance and complaints processes.
- Risk Management
- Training of personnel - including ISO 13485, FDA QSR (cGMP), Europe MDR