CE marking for medical devices in accordance with the Medical Device Regulation
Are you finished with designing, developing, manufacturing and ready to enter the market? When trading medical devices on the European market, obtaining the CE-mark is mandatory for every company or entity. With the CE-mark you will declare that the medical device is in accordance with all legal requirements of the European market. The Medical Device Regulation 2017/745 is a set of requirements and processes for you as responsible party. When your medical device is in accordance with this set of requirements, the CE-mark can be affixed and the medical device can be legally introduced to the European market.
Solutions for legal market access
As responsible entity you have to ensure the medical device and its documentation are clear-cut and waterproof. Where do you start? Every case is different and has its own unique characteristics. Therefore, we offer a swift and tailored certification of your medical device. With this certification process Certification Experts guarantees your medical device and documentation meet all mandatory pro
The certification process
We based our process approach on the basic need of our clients. The certification process is a comprehensive set of steps in which we carefully follow our standard guideline for the realization of market access.
Identify EU requirements for your machine
Assess level of conformity and testing
Risk Assessment of the machine
Assistance and review of the technical documentation
Machine is certified and can be traded in the EU
Benefits of Service
- Realizing easy market access
- Short and flexible lead times
- Knowledge sharing for future certification
Price and timeframe
Price ranges could vary based on the circumstances beforehand and therefore are given on request. The lead time is approximately two till four weeks depending on the given conditions. The timeframe and price are closely intertwined with the following factors:
- the applicable legal framework
- the availability of the technical documentation
- the degree of compliance
Do you want to know the price and timeframe for the certification of your medical device?
Get free quote
Our partnership with Certification Expert helps to bring high added value to our Industrial AI & IoT computer platforms, furthermore their services contribute to purse our objective of making AI&IIoT solutions easier to adopt for our customers.
‘It was a pleasure to work with Certification Experts. After reviewing our documentation, they gave us structured feedback and showed us a way forward to compliance with EU directives.’
‘We found the collaboration with the CE Team very helpful, professional, fast and flexible. It is always good to have a partner at hand who can help with profound expertise whenever required. In the future, CE will stay our choice if expert-know-how is needed.’
‘The test results during the certification project were comprehensive and detailed. We experienced this as a pleasant and valuable result. In addition, Certification Experts swiftly came up with solutions for obstacles we encountered during the certification process.’
“CE is our partner for over 10 years and the relationship is outstanding. The face-to-face meetings are really important and safe us a lot of time.“
“The team of Certification Experts consists of nice people, it was a good cooperation! For me it was important how they made everything clear and how they thought along the same lines.”
Lars van ‘t Kruijs
“Personally I am very satisfied with the service and quality of the work of Certification Experts. With future projects, I certainly intend to work with them again.”
“The collaboration with Certification Experts runs smoothly and they are a valuable partner for us. If Dutch companies require specific technical information about the Comprehensive Economic & Trade Agreement on free trade, Certification Experts is the first to call.”
Melanie ter Meulen
“The cooperation with CE goes satisfactorily. They were decisive from the start and things were well taken care of. I see the problem-solving capacity of Certification Experts as a strength of the company.”