Medical Device Industry

The medical device industry represents a leading force in delivering safe and effective healthcare solutions. The industry has created numerous life-saving technologies, as well as products that improve the overall quality of life. Technology breakthroughs, including genomics-based tests and analyses and micro-surgery techniques, contribute to early disease detection and replace and/or work in concert with drug-based treatment options, thus contributing to the transformation of healthcare systems throughout the world.

According to the Advanced Medical Technology Association (AdvaMed) industry trade group, "more than 80% of medical technology companies have fewer than 50 employees and little to no sales revenue. The lifecycle for many advanced technologies is two years or less. Delays in gaining [ US ] FDA approval and Medicare coverage can mean life or death for smaller medical technology companies." These factors, as well as emerging regulatory and market trends in the US and throughout the world, contribute to the breadth of exciting opportunities for and challenging obstacles to developing and marketing medical device solutions.

The medical device industry and associated regulatory agencies (e.g., US FDA Center for Devices and Radiological Health (CDRH)) have led the way in promoting a more progressive, risk-based approach to compliance. The General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 2002 PDF)outlines general validation principles that the FDA considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. The usefulness of this guidance has resulted in its becoming a primary computer system validation (CSV) resource for non-CDRH regulators, as well as all those in other life sciences industries. The US Quality System Regulations (QSRs) (21 CFR Part 820) outlines requirements related to the methods, facilities, and controls used for medical devices and addresses risk analysis and risk management principles.

How Patni Can Help
Patni's service portfolio covers US FDA and non-US and international regulations and guidelines. Our experience and expertise spans the product life cycle, from laboratory analysis, through clinical development and product complaint tracking. Our risk-based approach to compliance is well-suited to the medical devices industry.

Patni assists clients in their goal of achieving and maintaining compliance with the Quality System Regulation (QSR) for medical devices, the Mandatory Device Reporting (MDR) requirements, 21 CFR Part 11 compliance, and other applicable FDA regulations and International Organisation of Standardization (ISO) guidelines governing medical devices.

Our knowledge of quality standards is key to our work on quality management systems with major clients.

Patni Services for the Medical Device Industry