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      Medical and healthcare equipment

      You created an amazing product that will positively impact countless people's lives, but you can't sell it without meeting regulatory requirements meant to keep people safe. Now the clock is ticking and you will need a partner with vast experience and Globally recognized accreditations.

      Speak with Us Now

      Nemko electrical medical device testing services offer unmatched support in the field of testing, inspection, and certification.  Nemko can confidently guide your organization through the complex certification and approvals process with ease.

      Choosing Nemko as a partner will reduce cost and time to markets. Nemko test reports and certificates are recognized and accepted for national approval applications.

      Optimising the approval process

      You get test reports according to international standards for safety, EMC, telecom and environmental requirements to demonstrate conformity with national requirements.

      We perform quality management audits as joint audits for several countries.

      We are your local partner

      By contacting your local Nemko team you get access to our experts. They are handling your projects and following up on the delivery. Nemko has test facilities for healthcare equipment in America, Europe and Asia.

      • IEC 60601-1 (General requirements for safety), IEC 60601-1-xx (Collateral) and IEC / ISO 60601-2-xx / 80601-2-xx (Particular) series of standards. Nemko can assist you to ensure product compliance within more than 50 Particular standards
      • CB certificates, 52 participating countries
      • EMC and telecom testing
      • RoHS testing
      • Reach and WEEE services
      • Climatic and environmental testing
      10 Steps to Medical Device Approval

      10 Steps for achieving medical device approval

      A simplified roadmap to help guide you through the regulatory review and approval process applicable to medical devices in most major markets.

       Learn More about Medical Device Approval

      Related pages
      Project Management Expertise During the testing process, there can be issues that come up and stall the timeline of the project. Nemko offers complete project management expertise to avoid any unnecessary delays. Read More about Project Management Expertise
      Test Preparation & Planning Before a test can begin, there is a preparation and planning period to establish the testing schedule, which will in turn make sure your tests are performed as efficiently as possible. Read More about Test Preparation & Planning
      Safety Testing Medical devices are among the most highly regulated products found in the market today. Make sure your product complies with these standards to ensure the highest level of safety at all times. Read More about Safety Testing
      Electromagnetic Compatibility Testing (EMC) Nemko offers comprehensive global EMC testing and certification services within regulatory requirements for a wide range of electro-medical devices. Read More about EMC
      Wireless device certification As more and more products gain wireless communication features, taking the regulations into account is mandatory for interoperability. Read More about Wireless Device Certification
      ISO 13485 Quality Management System ISO 13485 is used by organisations involved in one or more stages of the life-cycle of a medical device. Read More about ISO 13485
      Environment and sustainability Large companies now see a need to reduce their carbon footprint and declare their level of sustainability or the sustainability of their products. Read More about Environment and sustainability

      Get your
      medical devices to market fast!

      Nemko will guide you step by step, so don't wait - reach out today.

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