Therapeutic Areas · Medical Devices
Device and diagnostics development spans hardware, software and companion diagnostics, each with distinct regulatory and evidence requirements.
Overview
Device and diagnostics development spans hardware, software and companion diagnostics, each with distinct regulatory and evidence requirements.
Guosa Life Sciences supports device programs with specialized study designs, human factors expertise and post-market surveillance.
Areas of Expertise
Specialized Capabilities
Why GLS
Our integrated enterprise combines scientific depth, operational excellence and collaborative partnerships to support development across diverse and demanding research environments.
The capability
We support device, diagnostic and digital health development: clinical investigations of medical devices, performance evaluation of in vitro diagnostics, and clinical evidence generation for software as a medical device.
Device evidence generation differs from drug development in ways that catch teams out. There is often no blinding, the operator is part of the intervention, learning curves affect early results, and the comparator may be a clinical pathway rather than a product. Design has to account for all four.
Regulatory considerations
In the European Union, the Medical Device Regulation and In Vitro Diagnostic Regulation set the framework, with the clinical evaluation report and performance evaluation report as the central documents. Evidence requirements scale with risk class, and for higher-risk devices the expectation of prospective clinical investigation rather than literature-based equivalence has increased substantially.
Software as a medical device raises its own questions: what constitutes a version change requiring re-evaluation, how algorithm performance is monitored after deployment, and how training data provenance is documented where the software incorporates machine learning. Post-market clinical follow-up is a standing obligation rather than a closing activity, and the plan for it should be written while the pre-market evidence is being generated.
How an engagement runs
Risk classification, evidence requirements and the route to clinical evaluation or performance evaluation defined.
Investigation or performance study designed for the device context, accounting for operator effects and learning curves.
Investigation delivered with device accountability, deviation management and adverse device effect reporting.
Clinical evaluation or performance evaluation report prepared, with a post-market clinical follow-up plan.
What you receive
An evidence strategy mapped to risk class. A study design accounting for device-specific bias. Device accountability and adverse device effect records. A clinical or performance evaluation report with a follow-up plan.
Evidence and context
Our operating assumptions are published rather than asserted. The Future of Clinical Trials in Africa sets out why study performance is increasingly determined by ecosystem maturity rather than site selection, and The Untapped Advantage makes the case that institutions, not regions, are the right unit of qualification. Both are available in full, with executive briefs for readers who want the argument in a shorter form.
Other Therapeutic Areas
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ExploreDiscuss your medical devices program with our multidisciplinary team.