We make the process as painless and straightforward for you as possible.
1. First, we recommend a preliminary discussion to assess your needs.
2. Next, you sign a contract allowing us to act as your Authorized Representative (AR).
3. The next step is to review your situation, specifically the product for which you’re seeking regulatory approval and its product “class," whether it's a medical device or in-vitro diagnostic. The documentation for both products is very similar, but companies must still stipulate how they classify their products and why. If your product is considered a medical device, it must be certified by an additional person (or "notified body") approved by the country where you'd like to sell your product; this separate process usually takes about two years, and we can walk you through it as well.
4. Then you'll provide us with any documentation you may already have. If you are starting from scratch, no problem; we'll assist you in compiling the paperwork and making sure it will satisfy the requirements of the competent authority with which we register your documentation.
5. We submit your registration package.
Aplos Device Regulatory Compliance UK Ltd is registered in England with Companies House. Our UK office is located at:
14 Windermere Road
London N19 5SE
United Kingdom
Nearest Underground: Archway (Northern line - High Barnet branch)
Note: Our offices will soon be moving to Hertfordshire.
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