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ready to access any global market
From expert consulting to full-service solutions, our specialist medical team can handle all your compliance requirements
Certification Experts has over 25 years’ experience handling classification and certification of medical devices according to the MDD and Medical Devices Regulation 2017/745 (MDR).
Obtaining CE Mark certification can be a complex and lengthy process. As your full-service compliance partner we can take this burden off your team, freeing up more of your time
Alongside our start-to-finish compliance service for medical devices, we also offer expert consulting and advice on classification and other regulatory issues.
An all-in-one compliance partner you can rely on
Together with notified bodies we handle the entire compliance process for you, freeing up your time so you can focus your expertise where it really matters
Get specialist MDR compliance advice
Unsure if your product classifies as a medical device or if you need a quality management system like ISO 13485? Our specialists can advise you on a range of medical compliance issues
Comply with all legal regulations in your markets
Our dedicated team handles gap analysis with the MDD-MDR, performs clinical trials and reviews according to all relevant EN/ISO standards, and assists with legal registration
A simpler path to your EU declaration of conformity
Compiling the right paperwork can be daunting and time-consuming for producers of medical devices. Our experts help assemble and verify your technical file so all paperwork, labelling and manuals are correct
Authorised Representation
If you’re based outside the EU orUK and want to sell your medical devices there, we can act as your AR (Authorised Representative), verifying your technical documents & products and allowing you to enter these markets
INSIGHT
Whether you’re looking for expert consulting on a compliance issue or need a full-service certification partner, we’ve got you covered.
the legal framework for your medical devices
the route to compliance
the conformity assessment procedure
can be affixed and the certificate signed
your product worry-free to the desired market
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Enter any market, no matter the marking or industry. From CE marking and UL to CCC, we offer complete certification guidance and expert services tailored to your unique situation.
We provide Authorised Representation (AR) for businesses and e-commerce companies located outside the EU/UK – allowing access to those markets by registering us as your legal partner.
Every manufacturer requires a technical file to reach compliance. We support, compile and review these technical documents for you.
We review your designs and assist you through the prototype phase to ensure critical safety standards are met.
Wherever you’re located, we offer a wide range of expert testing and inspection capabilities, both in house and via our global network of affiliated partners and testing laboratories.
We create a clear and practical compliance roadmap for you in any market. Get expert guidance on cost/time efficiency of certification for accessing multiple markets.
We help you eliminate risks more efficiently, protect your customers and your business. Unsure whether you’ve done something correctly? We can provide a full risk assessment evaluation.
Make sure your manuals, labelling and packaging are fully compliant with your
chosen markets. From writing to reviewing materials, we’ve got you covered.
We offer custom training programs led by experts, bringing your team up to
speed with important safety processes and regulations related to your markets.
With over 25 years’ industry experience, our team can provide expert guidance
on every aspect of product compliance.
