Medical Device Compliance |
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K2C provides consultancy services dedicated to medical devices producers, mainly focused on compliance to applicable regulation and standard.
Medical Devices producers have to comply to a wide range of regulation requirements, also depending on the specific product category and/or final markets.
We fully assist the producer in all activities required to
obtain and maintain the regulatory authorisation,
providing the following consultancy services:
Implementation or review of company Quality Systems
Management of communication with regulatory agencies and associated practices
Preparation of technical dossiers
Validation Life Cycle and associated activities
Supplier Qualification
Preparation to ISO or similar certification when required
Clinical Trial management when required
Training on regulation and best practices