Are you looking for a Medical Device consultant to register your product in EU / USA / Australia /New Zealand?
We worked for Notified Bodies as auditors for ISO 9001 and ISO 13485 (including Canadian requirements), MDD 93/42 EEC, MDR, MDSAP, CMDR (Health Canada) and 21CFR820. We are experts on creating QMS from scratch and regulatory applications (Tech files for EU and 510k submission in the USA), if you have a medical device you need to register – we will get you over the line.
With 20 years’ experience in the medical device industry, both managing Quality and Regulatory Affairs, and as an active auditor, we certainly understand the intricacies of the market. Our knowledge of the critical aspects of a business that influence product quality and compliance, means we are particularly focused on achieving a balance between risk and commercial rewards. Ensuring the Quality Management System supports the business needs as well as meets regulatory compliance goes without saying.
We are highly motivated and devoted QA/RA professionals. We list our standout traits as the following:
- Technical expert
- Creative thinker
We are highly experienced and educated professionals who can be counted on to deliver the systems, documentation, and advice required, and we pride ourselves on having achieved 100% compliance for all clients we have ever worked with.
We are Qualified Auditor for ISO 9001 and ISO 13485 (including Canadian requirements), MDD 93/42 EEC, MDR, CMDR (Health Canada) and 21CFR820.
MDD 93/42 EEC / MDR
CMDR (Health Canada)
What others are saying …
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.
I would gladly work with Alexander in the future.
Product Ideation Consultant