Every manufacturer of medical devices is required to compile and to keep up to date a technical documentation set. Unitron Regulatory offers support in building your technical documentation and meeting obligations in order to bring your medical device or life science device to the market. We can also conduct an assessment of your existing documentation for certification and design transfer necessities.
Bringing a (medical) device to market can be quite a hassle. There are lots of aspects to take into account and many legislative requirements to fulfil. If something is unclear, or if you are just looking for a second opinion, Unitron Regulatory offers regulatory advice.
We offer internal and external support within certification processes. We write regulatory documentation and support in risk management activities. We can also speak for you and alongside you to Notified Bodies and testing facilities, to support in discussions about regulatory and technical topics.
We offer support and keep you updated about changes regarding standards and regulations. We perform gap analyses for regulations and standards applicable to your product and follow up any identified gaps.