Clinical Investigation of Medical Devices

The clinical development process largely differs from that of Drugs to Medical Devices. The Medical Device industry continuously works on developing various guidelines and standards to boost efficiency, effectiveness, patient safety and helps companies by harmonizing clinical trial processes as transparently as possible, so that it incorporates the understanding of multiple health authorities and these drug / device developers will have wider acceptability for their efforts and the data generated from clinical studies across the globe. If the volume of work is compared Pharmaceutical industry has anytime had bigger operations than Medical device industry, directly resulting in higher turnover, and eventually requiring investments for better and harmonized guidelines and standards.

In past few years there have been drastic changes, rather growth in the medical device industry, and it saw competition coming from other industries as well as enthusiastic garage software developers. For an industry so diverse in the type of technology, product, applications and backgrounds, on a global level is adding continuously tremendous pressure on the industry leaders and advisors to have its own, set of guidance and standards, harmonized and clarified, for easing and leveling a global playing field for Medical device companies, instead of borrowing from Pharmaceutical.

ISO 14155:2011 "Clinical investigation of medical devices for human subjects? Good clinical practice" Guideline has been revised to address the differences between device and drug studies and now generally accepted as harmonized with ICH GCP.

Key Benefits of ISO 14155: Language, Recognition, Monitoring, Operations and Data Transportability

Goals of ISO 14155:

• Protect the rights, safety and well?being of human subjects
• Ensure the scientific conduct of the clinical investigation and the credibility of the clinical

Investigation results

• Define the responsibilities of the sponsor and principal investigator
• Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved

in the conformity assessment of medical devices.

Conclusion:

With major revision to ISO 14155:2011, Harmonization with US GCP & ICH E6, similarity with Japan GCP,

closely followed by EU and harmonized with MDD, officially accepted as a standard by US FDA, no contradiction with other GCPs, much improved and detailed verbiage and definitions, keeping abreast with advances and best practices in the industry, integration of essential project management, reporting, quality, and risk management principles, completely focused for Medical Device trials, and enhancing the data transportability among countries, presents a good platform to debate the use of ISO 14155:2011 as the foundation for local and international Medical Device Trails.

MakroCare has an extensive experience and understanding of Clinical Investigation of Medical Devices and strong team of scientific, regulatory, clinical marketing and diagnostics who are spread across US, EU, Bric and Asean.