IM3 Consulting Group
Performance Testing - Protocol & Report Review
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The heart of any regulatory submission or technical file/design dossier is a compilation of data from various test protocols intended to establish safety & efficacy. The success or failure of a regulatory submission is largely dependent on this information. We have specific expertise in the following areas, and have a complete understanding of all applicable test standards. We also understand statistical design, required to develop product-specific verification & validation test protocols.
· Biocompatibility of device materials per ISO 10993
· Software Validation according to FDA Guidance & IEC 62304
· Electromagnetic Compatibility and Electrical Safety Testing per ISO 60601-1 and 60601-1-2
· General bench testing including protocol design
· Animal Testing including protocol design
· Clinical Testing (done in conjunction with our CRO partner)