Medical Device Technical Documentation
Preparing, completing, collating and maintaining your medical device Technical Documentation to evidence:
- Intended Use, Device Safety & Performance
- EC / UK & other Country Classification
- Predicate(s) / Substantial equivalence
- Risk Management
- UDI / Labelling
- Attainment of ISO / National Standards
- Clinical Evaluation
- Compliance with country specific regulations
- Declarations of Conformity
Determining the risk category / profile and intended purpose of your medical devices to establish the feasibility of defining specific groups or categories of devices for which one Technical File may be possible for each group or category. We will prepare and collate compliant Technical Documentation to meet national regulations including:
In accordance with your Regulatory Strategy, and specific country / national requirements we support you to successfully achieve the CE / CA Mark, 510k Regulatory Clearance, Listing or Licensing as appropriate.
Expertise
Using experienced, qualified dedicated staff we prepare, review, collate & maintain medical device Technical Documentation to a defined, readily accessible structure to meet EC and other national regulations for countries such as:
- Australia
- Brazil
- Canada
- China
- EC Member States
- Japan
- Mexico
- Saudi Arabia
- South Korea
- UAE
- USA
