Services
Regulatory
In the ever-changing world of regulatory affairs, it is critically important to fully understand the mandatory requirements that apply to your product(s). ALPA Medical can help you place your product(s) on the market, from the initial concept all the way through to regulatory submissions and post-market surveillance.
- Direct with a senior lead auditor You work with Alberto himself, with no account managers and no hand-offs.
- Pragmatic, not paperwork Practical guidance that removes the unnecessary documentation burden.
- Tailored to you Every step is tailored to your product(s) and your quality system.
Our expertise
We can help you with the following
-
Europe
CE Marking
-
United Kingdom
UKCA marking via the MHRA, with CE marking still accepted during the transition
-
USA
FDA
-
Canada
Health Canada
-
Japan
MHLW
-
Brazil
ANVISA
-
Australia
TGA
-
MDSAP
Includes Canada, Brazil, USA, Australia and Japan
Get in touch
Which markets are you targeting?
From CE Marking and UKCA to FDA, Health Canada, ANVISA, TGA, MHLW and MDSAP, tell us where you want to place your device and we’ll map the route.