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Define requirement specifications, perform pre-market medical device testing and deliver accredited test reports to applicable standards supporting market access.

Medical device manufacturers must document that devices meet applicable regulatory requirements for safety and performance before products can be introduced on the market. The need for testing typically arises during product development, design verification or preparation of regulatory submissions, where requirements from frameworks such as the EU Medical Device Regulation (MDR) and applicable international standards must be translated into clear test documentation. When requirements are unclear or testing activities are not coordinated, development projects can face repeated testing cycles, redesign and delays in regulatory review. 

 

Testing across relevant technical disciplines 

The service provides documented evaluation of device safety, performance and reliability through accredited testing and technical assessment. Activities may include electromagnetic compatibility tests (EMC), electrical safety tests, mechanical and climatic tests, and reliability tests in accordance with standards within the IEC 60601 series. Depending on the device characteristics, specialized tests such as audiological tests or photobiological safety tests may also be in scope. Accredited test reports provide traceable documentation suitable for inclusion in technical files and regulatory submissions. 

Hospital intensive care room with patient bed, monitoring equipment and medical devices in clinical use, illustrating the context where medical device testing supports safety and performance verification.
Hospital environment where medical devices such as patient monitors and life-support equipment are used in clinical care.

Challenges

When regulatory requirements are unclear, product development can stall, delaying market access.

Regulatory misinterpretation delays approval

Misinterpreting applicable legislation and standards can delay regulatory approval and force redesign. Manufacturers must understand and apply requirements early in development, as errors often lead to rework, additional testing cycles and extended timelines.

Documentation gaps block market acceptance

Incomplete technical documentation can result in non-acceptance by notified bodies or regulators. Risk management file, conformity requirements and test reports must align with regulatory expectations, as gaps can prolong or halt the approval process.

Poor test coordination increases cost and time

Lack of coordinated testing across disciplines can drive up costs and extend project timelines. Medical devices typically require aligned EMC, electrical safety, mechanical and climatic testing, and without integrated planning, inefficiencies and delays arise.

Benefits

Deliver practical testing outcomes that support compliant product submissions and timely approvals

Defined requirements, clear compliance path 

Early review of applicable regulations and standards defines the correct test scope and reduces uncertainty in the conformity planning process.  

Immediate design feedback, fewer retests and delays 

Pre-compliance and accelerated life testing provide early, data-driven feedback on design performance, helping prevent costly redesigns and repeated formal testing.