Every medical device manufacturer or company would agree with us when we say navigating through the regulatory playfield is one of the most challenging, daunting, and time-consuming tasks. This is why most medical device manufacturing companies prefer outsourcing their regulatory services to professionals. Luckily, several medical device regulatory consulting agencies in the United States can efficiently help you drive through all your regulatory requirements.
Today, we are going to share the most trusted medical device regulatory consulting agencies. These agencies serve as indispensable partners for companies seeking assistance in navigating the intricate regulatory frameworks governing the development, approval, and commercialization of medical devices.
From startups to established enterprises, these consulting firms offer tailored solutions to streamline the regulatory process, mitigate risks, and expedite market entry. While we are at it, we highly recommend you check out what are the major challenges every medical device company faces. Not just this, if you are confused about whether to outsource regulatory services, our article on the Pros and Cons of Hiring A Medical Device Consultant.
List of Trusted Medical Device Regulatory Consulting Agencies In The US
⦿ Elexes Regulatory & Quality Compliance Consulting
⦿ MWA Consulting
⦿ Sigma Management Systems
⦿ Apotech Consulting
⦿ QES Medical
⦿ Rook Quality Systems
These are the most trusted medical device regulatory consultants in America. Let’s dive into knowing each one of these companies one by one.
Elexes Regulatory and Quality Compliance Consulting
Elexes is one of the trusted regulatory consulting agencies started by one of the industry leaders Parul Chansoria who has 50+ years of experience. They specialize in providing regulatory and quality support not only for medical device companies but also for food companies, cosmetic companies, hospitals, and clinics.
Services they offer:
✓ Product development and design support
✓ Compliance assessment
✓ Regulatory gap analysis
✓ 510(k) submission
✓ Compliance audits
✓ MDSAP
✓ Clinical evaluation report support
✓ Quality (QMS) Support
✓ Regulatory due diligence
✓ Import/Export regulatory support
To find out more about what services they offer click here.
Website: https://www.elexes.com/
Contact: +1 408-475-8091
MWA Consulting (Medical Device Regulatory Consultants)
Another one of the companies that make up the list of top medical device regulatory consultants is MWA Consulting. Based in the US, Canada, India, South America, and Europe the company has over 300 experienced associates.
Services they offer:
✓ QMS building
✓ Preventive maintenance
✓ 510(k) submission
✓ Risk management
✓ Internal audits
Website: https://www.mwa-consulting.com/
Contact: +91 866-497-7787
Sigma Management Systems
If we are listing the trusted medical device regulatory consulting companies, how can we leave out Sigma Management Systems? The company has a team of expert professionals who offer end-to-end support for all medical device regulatory requirements.
They usually help companies with tasks such as:
✓ Technical file creation
✓ CE Marking
✓ QMS gap analysis
Website: https://www.sigmasystems.net/
Contact: +381 64 301 8 391
Apotech Consulting
Apotech consulting is a lot more than a medical device regulatory consulting agency. They also specialize in providing quality and engineering support to medical device manufacturing companies and companies. With its contract service organization (CSO), Apotech positions itself as a perfect outsourcing partner for the end-to-end medical device development and approval process.
Services they offer as medical device regulatory consultants:
✓ Quality assurance
✓ Internal audits and training
✓ CER writing
✓ 510(k) submission
Website: https://apotechconsulting.com/
Contact: +44 (0)2039062880
QES Medical Regulatory Consulting
QES is a Boston-based medical regulatory service that severals both medical device and pharmaceutical companies. With 18+ years of experience, the Founder and President Oscar Garcia is one of the leading industry experts.
Services they offer:
✓ QMS building and support
✓ Regulatory compliance with key standards including ISO 13485 & FDA 21 CFR 820
✓ Design and development support
✓ Risk Management
✓ Audit readiness
Website: https://www.qesmedical.com/
Contact: 1-978-885-1274
Rook Quality Systems
For more than a decade, Rook Quality Systems has been helping medical device companies with their regulatory services. Their experienced and certified quality auditors often provide the best support for the key medical device regulatory and quality
Services they offer include:
✓ The MDSAP
✓ EU MDR CE Marking
✓ ISO 13485
Website: https://rookqs.com/
Contact: 770-833-0116
These are some of the best and most trusted medical device regulatory and quality compliance consulting agencies in the US. Each one of these companies has established its place in the complex world of regulatory affairs by helping different medical device companies and manufacturers with their product approval, process quality, and regulatory requirements. Although above, we have the list of the best medical device regulatory consultants in the United States, still the choice will depend on several factors.
To avoid the mistake of choosing the wrong consulting agency, go through the Complete Guide on Hiring a Medical Device Consultant. Here you will learn about the importance of hiring a consultant and things you should consider while hiring one.
