Uncertainty breeds anxiety. And medical device manufacturers have plenty of reasons to be anxious. The current device risk climate has caused reputational damage to the entire industry.
Medical devices have caused nearly 80,000 patient deaths and over 2 million injuries in the past decade, according to a study by the International Consortium of Investigative Journalists. Harmful devices have included the power morcellator, faulty metal hip replacements, malfunctioning pacemakers, and scary robotic surgeons.
Fortunately, you don’t have to figure out how to avoid a risk nightmare by yourself. A qualified medical device risk management consultant can help you resolve safety issues and, ideally, remove your anxiety that your products could harm the end-user. Here are five of the best device risk consultancies.
Reviewing the Top Medical Device Risk Management Consultants
Medical device risk management is definitely not a topic that manufacturers can ignore until post-production. The sooner you can build a solid quality management system foundation on good manufacturing practices (GMP) and ISO standards, the better.
The ISO 14971:2007 and 2012 standards for medical device risk management have shaped the global framework for safety throughout the product life cycle, which begins with “inherent safety by design.” Achieving 14971 certification can help manufacturers achieve compliance with FDA GMP and other major global regulatory requirements. 14971 is a framework to avoid releasing a device with unforeseen safety risks.
While ISO 14971 is critically important, hiring an ISO consultant to implement the standard isn’t necessarily the right solution for everyone. Consider whether you need project-based support or long-term help with risk management.
Be realistic about your own needs and what it’s going to take to build risk management into the entire product lifecycle. Use that knowledge to select the right consultancy.
Emergo offers specialized ISO 14971 risk management consulting services for medical device manufacturers, including startups, scale-ups, and bigger manufacturers with an existing ISO 13485 quality management system. The firm describes 14971 as a systematic approach to creating, documenting, and managing risk. Emergo’s two-step process involves gap analysis and, then, guiding clients to create a risk management process and file.
According to Emergo’s website, their team of consultants has experience with device risk management at hundreds of manufacturers, including Class 1, 2, and 3 manufacturers. Emergo is a global consultancy specializing exclusively in compliance and innovation for medical devices and in-vitro diagnostic (IVD) clients. Their team of over 1,000 consultants works from 29 office locations worldwide, including US offices in Chicago, Austin, and Concord, MA.
Intertek provides medical device risk management consulting, with particular specializations in ISO 14791 and IEC 60601-1, an international standard for product safety in medical devices. An engagement with Intertek offers support building a risk management file that’s compliant with ISO and IEC standards, including process support for risk analysis, hazard analysis, and monitoring.
Intertek relies on a three-step process, which begins with assessment of a manufacturer's current regulatory strategy. Next, Intertek works to create a risk management process, file, and analysis components per IEC 60601-1, and performs long-term planning for compliance. Intertek has an impressive 130 years of history and a staff of 44,000 employees who work from over 1,000 locations worldwide. In addition to device risk and life sciences consulting, the consultancy specializes in quality consulting for numerous other industries such as chemicals, retail, and aerospace.
RELATED READING: Is Your eQMS Built for ISO 14971 Risk Management Compliance?
Maetrics employs a three-part approach to medical device risk consulting, which involves analyzing risk, creating a risk management strategy, and monitoring the long-term results of risk controls. Founded in 1984, Maetrics is an international consultancy that focuses exclusively on life sciences industry clients, with office locations in Great Britain, Switzerland, and Indianapolis, Indiana.
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Oriel’s device risk management consultancy is focused on the ISO 14971 framework. Per Oriel’s website, their consulting team has extensive experience implementing ISO 13485 quality systems and FDA cGMP. The firm also specializes in helping established manufacturers integrate ISO 14971 requirements into a “new or existing” ISO 13485 quality management system.
Oriel was founded in 1968 by an applied statistician. They’re likely best known for their “STAT A Matrix," a decades-old statistical approach to implementing Lean and Six Sigma manufacturing techniques in life sciences. Oriel is focused exclusively on quality and regulatory consulting for device and life sciences organizations and providing quality training courses. Oriel’s headquarters are located in Union, New Jersey, in addition to a global presence and multilingual staff in 18 countries worldwide.
RELATED READING: The 6 Best Medical Device Regulatory Consulting Services
MedMarc isn’t your typical medical device consulting firm, though they do provide risk management and FDA compliance consulting to life sciences companies. Instead, they’re a business services firm described as the leading solution for “products liability risks facing medical technology." MedMarc offers insurance to device manufacturers and legal services for life sciences organizations facing claims.
The firm’s risk management consulting services are offered “complimentary or at a discounted rate” to companies that carry risk insurance through MedMarc. The firm’s specializations include risk evaluation and employee training. MedMarc was founded in 1979 by AvaMed, the world’s largest MedTech association. The company is headquartered in Chantilly, Virginia.
Medical Device Consultants and Risk Management
A qualified consulting firm can help you avoid safety issues, waste, and excessive costs by creating a comprehensive risk management file. Consultants can offer value in numerous ways, including helping manufacturers achieve ISO 13485 and 14971 certification, or adding 14971 requirements to an existing quality management system.
Make sure you’re hiring the right consultant and that the services they offer align with your requirements. Don’t opt for ISO 14971 implementation specialists when you need to take a few steps back and start with an ISO 13485-compliant QMS. Consider fully outsourcing your risk management if you lack the internal resources to do it yourself.
Qualio is the world’s leading enterprise quality management system (eQMS) for medical device companies with up to 500 employees and goals of growing quickly. We can recommend several specialized medical device risk management consulting firms that work with Qualio and have an excellent track record. Start a conversation with us today, and we’ll be happy to help you find the best consultant for your needs.
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