We, Rescisco Global Regulatory consultants, intended to offer quality and regulatory services to the manufacturers of medical devices including in-vitro diagnostic medical devices from conceptualization stage to marketing as per the requirements.

Testing & Assessment

Evidence Is Everything. We Build It Right.

Regulatory bodies don't approve products on the basis of claims — they approve them on the basis of evidence. Our Testing & Assessment service ensures that every test is designed, executed, and documented in a way that answers the specific questions regulators will ask.

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Chemical & Material Testing

Biocompatibility assessment per ISO 10993 series: cytotoxicity, sensitisation, irritation, systemic toxicity, genotoxicity. Material characterisation, extractables & leachables.

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Biological Safety Testing

Sterility testing, endotoxin/pyrogen testing, microbiological evaluation, and bioburden determination per ISO 11737 series for sterile devices.

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Mechanical & Physical Testing

Fatigue, tensile strength, dimensional verification, packaging integrity (ISO 11607), shelf-life and accelerated ageing studies, and transportation simulation.

Electrical Safety & EMC

IEC 60601-1 electrical safety, IEC 60601-1-2 EMC testing, IEC 60601-1-6 usability, and IEC 60601-1-11 home healthcare environment testing.

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Software Verification & Validation

IEC 62304 software lifecycle, SOUP management, software hazard analysis, verification and validation protocols, and cybersecurity testing per MDCG guidance.

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Clinical Investigations & Pre-Clinical

Protocol design, ethics committee submissions, investigator site qualification, CRF design, data management, and clinical study report preparation per ICH GCP.

"Poorly planned testing is the single biggest source of regulatory delay. We design your testing programme once, correctly — so your data answers the right questions the first time they are asked."

— Rescisco Global, Testing & Assessment Practice