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December 13, 2021updated 13 Jan 2022 4:21pm

Medical Device Testing and Compliance

By Nat Schaefer

Medical device manufacturers need to comply with stringent regulatory standards such as those set out by the US Food and Drug Administration (FDA), International Standards Organisation (ISO) and ASTM International, to successfully move their products to market.

Medical device testing assesses a medical device’s performance, material, and biocompatibility in terms of reliability and safety, also extending to rigorous design validation testing and packaging verification.

Finding medical device testing companies

Medical Device Network has listed the leading medical device testing and compliance service providers based on its experience in the sector.

The download document is targeted at medical device executives, managers, test leads, quality control and quality assurance executives, software testers and engineers, test architects, manufacturers, distributors, suppliers, application specialists, and other individuals involved in medical device testing and compliance.

The document contains detailed information on the suppliers, their products and services, as well as their contact details, to inform your purchasing or hiring decision.

The list includes companies offering a range of services, including:

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  • Clinical trial management for medical devices
  • Medical device testing
  • Testing and software development for medical devices
  • Healthcare diagnostic systems
  • Electromedical device engineering and production
  • Complex medical material and component testing

The importance of medical device compliance

Medical device compliance is necessary to attain approval from regulatory bodies and facilitate quality audits, as well as ensuring product safety. Regulatory bodies can mitigate any compliance issues through corrective and preventive measures and complaint procedures.

Medical device software testing

Software malfunctions pose several risks to medical devices and patients’ wellbeing. Inadequate software testing may cause the risk of disclosing patients’ confidential health information, thereby failing Health Insurance Portability and Accountability Act (HIPAA) compliance. This damages the reputation of medical device providers.

Medical device software testing services include software validation, verification of the software requirements and design, code reviews and testing, and compliance verification.

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