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Unitron Regulatory

Your reliable partner for medical device certification support and advice

Unitron Regulatory is the right partner for product certification in the field of medical devices and life science devices. Our team has specialist knowledge and practical experience with regard to product certification (CE, MDD/MDR, IVDD/IVDR, LVD, FDA, etc.) of medical and life science electronic products and equipment. We are experts in the field of building up a technical product file and product life cycle management.

Do you need advice or assistance with the certification of your electronic device? Don’t hesitate and contact us! 

UPDATE: The MDR is postponed and the new date of application is 26th May 2021.
As a gesture to the medical device industry we would like to provide our own 'readable' version of the updated MDR.
You can find the download here.

Our services

Technical documentation

Technical Documentation

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.

Regulatory Advice

Regulatory Advice

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.

Regulatory Support

Regulatory Support

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.

Product Lifecycle Management

Product Lifecycle Management

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. 

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