Product development
A new Medical Device starts as an idea or significant improvement to an
existing product. Before market entry, new ideas need to be tested.
Depending on the device type different pre-clinical/biocompatibility tests and
clinical trails need to be carried out to ensure that devices placed on the market
and put into service do not compromise the safety and health of patients, users and,
where applicable, other persons when properly installed, maintained and used in accordance
with their intended purpose.
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ISO 10993 Biocompatibility testing:
Choose the right tests for your product as outlined in ISO 10993 based
on the chemical composition of your product, conditions of exposure and the nature, frequency and degree of exposure
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ISO 14155-1 Clinical Investigation – Part 1 General Requirements:
Make sure that you choose appropriate tests for your product based on ISO-14155-1
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ISO 14155-2 Clinical Investigation – Part 2: Clinical Investigation Plans:
Help you develop appropriate clinical plans
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Test of Literature review:
Help you decide to go for testing or to meet the requirements via bibliographical references
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