medical device regulatory consultants

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.

Posted in
Medical Devices

Keerthana

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