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Services / Electronic product compliance and testing / Medical device testing and certification for market access

Testing and approval of medical devices

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Timely testing and accredited documentation are critical for market access. We expedite the regulatory process, saving you valuable time and enabling faster, safer product approvals. 

Choose a test partner who knows how to get medical devices onto the market efficiently and safely 

We offer fast and comprehensive guidance, testing, certification and documentation services for medical device manufacturers. Based on our decades of experience, we know how to get you through the regulatory compliance process efficiently and safely.

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Need expert guidance on device compliance?

Get fast, expert advice on guidance, testing, certification, and documentation for medical device manufacturing.
Get advice
 
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Global testing expertise ensures compliance with international standards

We can guide you through the entire product approval process: 

  • Establish conformity requirements specifications for compliance with medical device regulations (i.e. MDR): applicable directives, standards, and derived test plans 
  • Pre-qualifications and accelerated life test (i.e. EMC/safety pre-test + reliability) contribute to "right the first time" product development, thereby saving time and cost. 
  • Get accredited EMC, electrical safety, mechanical, climatic, reliability, audiological and photobiological safety tests done, including testing towards standard IEC 60601. 
  • Benefit from our specialised test facilities, for instance for hearing aid testing. 
 
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"Thanks to all the testing we have done and our shared determination and solid partnership, we have now collected and summarised all necessary documentation. XVIVO's mission is to push the research forward; heart technology is only one example. Our partnership with FORCE Technology on testing the product from every angle is an instrument in achieving an innovative and safe product."

- XVIVO Medical Design Engineer Martin Ross.

Read more here

FAQ

  • Can FORCE Technology act as external regulatory affairs (R/A) partner?

    Yes, it is a core service at FORCE Technology to investigate the regulatory conditions for your specific product in designated markets. We call it "approval management" because it involves more than identifying requirements. It also includes managing the approval process as a project manager and assisting in compiling the approval documentation.

    It is essential for us to ensure that labelling, declarations of conformity and all other parts of the documentation are performed correctly without flaws.

    As a notified body, we know what we are talking about, and you can strengthen the validity of your documentation with a notified body certificate (see also the page Accredited product certification of electronic products).

  • Can FORCE Technology perform CB Scheme tests?

    Yes, as a CB testing laboratory, we provide CB-certified reports for a wide range of standards relevant to technical audiological products. We use FORCE Certification A/S as an impartial subcontractor for product certification.

    See our list of standards on the IECEE's website.

  • Does FORCE Technology offer approval guidance for medical devices? 
    Yes, our services include assistance with the intended use, use specification, classification, software, usability, risk management, national registrations and guidance on technical documentation. 
  • Is FORCE Technology a notified body for the Medical Device Directive (93/42/EEC) or the Medical Device Regulation (EU 2017/745)?
    No, we focus on electromechanical testing and medical software but collaborate with partners for certification and consultancy.
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What are the life science industry’s biggest technological challenges?

New report maps the technological challenges with digitalization and green transformation in life science companies.
Get the report here
 
green design of medical devices

Article

Green design of medical devices

How to use the standards to develop green design of your equipment.

For more information, contact

Compliance & Product Testing

Customer Centre: Consultancy, test and product approval

T: +45 43 25 14 50
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