Get It Right First Time, Every Time.
For all your Medical Device Quality Assurance and Regulatory Affairs needs
We’re not only Quality Management Consultants, we’re also active Auditors, which means we know EXACTLY what’s required to take your medical device to market quickly and effectively. Medical QMS is proud to have achieved accreditation for 100% of our clients.
We’re up to date with all changes in this area. We not only provide the advice you need but also create the exact systems and documentation required to get the auditor to say YES!
Whether you’ve previously failed an audit, are looking to expand into new markets and need to satisfy other regulatory bodies, or are a start-up with a fresh idea, Medical QMS can assist.
AustraliaUSAEuropeCanadaOur Services
We can assist you with all your Quality Assurance and Regulatory Affairs requirements. Our services include -
- Medical Device Quality System Setup
ISO 13485:2016 and 21CFR820 - QMS Solution
- QMS Internal audit
- QMS Pre-audit
- QMS Supplier audit
- MDSAP Audit
- Regulatory Affairs
- Australian TGA Sponsor Representation for Medical Device Companies
What others are saying …
I would gladly work with Alexander in the future.
Product Ideation Consultant
Alexander is also a people's person who has excellent communication and socializing skills and was very likable by everyone.
I'd love to work with Alexander in the future, and he has my warmest recommendations.
Q&R Director