Medical electrical euipment
To ensure that your product is safe for both patient & operator, we help you with product requirement & safety testing of medical device / medical equipment.
Nemko has extensive experience testing many kinds of medical equipment / medical device.Our testing laboratories feature advanced test equipment that can measure and stress your product to make sure it fulfils all compliance requirements for your planned markets. Our diverse and experienced team brings in-depth knowledge and understanding of various complex medical device / medical equipment technologies. The medical device / medical equipment market is expected to grow rapidly soon.
How Nemko can help :
- Provide pre-compliance testing requirements during the design and development phase
- Assist you with verification testing on qualified products as per requirement
- Support you with reduction of time to market
Through us you can access the following facilities:
- Medical Device Directive, Class I-m (measuring), I-s (sterile), IIa, IIb, III
- EC Declaration of Conformity; compiling of test reports and required documentation for the technical file
- EC Type Examination Certificate
- Full Quality Assurance with reference to EN ISO 13485
- Production & Product Quality Assurance with reference to EN/ISO 13485
- EC Verification
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