Often times it might be challenging to find the right consultant with good credentials that offers the right services. This list encapsulates reliable medical device consultants who are experienced professionals in their respective specializations. We included companies of varying sizes with different niche expertise.

From Research and Development, Device Classification and Submissions, through Quality Assurance to Post-market surveillance, and even selection of the right QMS software solution for medical device organizations.

We hope this list will help you find the right medical device consultancy. Otherwise, don’t hesitate to let us know what is missing.

THAY Medical

THAY Medical is a new innovative Human Factors Engineering consultancy based in the UK. They are an organization focused on providing expertise on human factors for medical products. This includes medical devices, healthcare systems, and pharmaceutical (Drug delivery) devices.

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ECT Healthcare Consultancy

ECT Healthcare Consultancy provides Regulatory, New Product Development, and Commerical consultancy services to the Medical Device and Healthcare Technology Industries. Collaborating with cutting-edge healthcare SMEs and larger OEMs. 

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Sensus Group

Sensus offers specialist consultancy, training and resource in delivering and implementing compliance of the new EU medical device (EUMDR 2017/745) and in-vitro (IVDR 2017/746) regulations.  

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Haughton Design

Haughton Design’s product design & medical device development services were created to deliver a first-class solutions to their clients. They provide a complete package, from concept design to industrialization, rather than just producing ‘aesthetic, blue sky’ design work.

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Psephos Biomedica

Psephos Biomedica was founded in 2001 and works with clients from around the world to help them bring medical technologies to market. They pride themselves on high focus and experienced team.

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Advena Medical

Advena Ltd. was founded in 1996 and provides cost-effective regulatory affairs consulting services to small and medium-sized medical device manufacturers and distributors seeking to import their medical devices into the European Union.

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Meddev Solutions

Team of experienced UK based medical device consultants, working in the medical device industry for both manufacturers and notified bodies. Meddev was voted the ‘Best-In-Class’ Medical Device Regulatory Consultancy company of 2020 by MedTech Outlook magazine.

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Flintloque Management Systems

Flintloque implements an International Management System Standard to help their customers access restricted markets and get a step ahead of their competition. Flintloque is a leading consultancy with rich experience.

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Regulatory consultancy specializing in providing advice and services to the medical device, combination product, and IVDD manufacturers.Particular expertise in new product development from idea through registration to commercialization and post-market activities.

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Triune Technologies

Medical Device Consultancy that offers hands-on support for quality systems, including ISO 13485, 21 CFR 820, CMDCAS, auditing, gap analysis, mock regulatory inspections, process validation, regulatory submissions on 510k, CE Mark.

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Sterile Management Systems

Auditing, training and consultancy services for medical device industry with a focus on design, quality management and regulatory compliance and special expertise in decontamination and sterilisation.

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Arevna Consulting

Arevna Consulting is a global solutions provider with over 20 years’ industry experience specializing in Quality and Regulatory compliance for Small, Medium, and Large scale Medical device manufacturers.

Arevna Consulting

Springboard Pro

Springboard specializes in the development of medical devices from concept to manufacture for regulated markets.

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Prosum Medical

Prosum specializes in the design, development, manufacture, commercialization, and distribution of medical devices for the global healthcare market. ​

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Lorit Consultancy

Lorit Consultancy offers consultancy, support, training and online-courses in functional safety related projects in the medical, automotive and reliability sectors. Medical: IEC 60601-1, IEC 62304, ISO 14971, IEC 62366-1, AAMI TIR57 Automotive: ISO 26262, Automotive SPICE®, SAE J3061, IEC 61508 Reliability: IEC 61709, SN 29500, FIDES and DO-178C and DO-254 Quality Management: IATF 16949, ISO 13485 and ISO 9001

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Alacramed was formed as a spin-out from leading biopharma life science consultancy Alacrita. This allowed Alacramed to enhance its focus on a growing number of medical device clients.

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GMP Healthcare

A team of more than 30 permanent professionals that includes experienced pharmaceutical consultants to provide support and advice across the product life-cycle. 

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International Device Solutions

Independent and nonexclusive consultant and subject matter expert for global pharmaceutical, medical device, financial and legal companies. From unmet needs to manufacturing control and scale-up.

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Clarity Compliance Solutions

Clarity Compliance Solutions is a leading international consultancy providing a wide range of compliance services for the regulated industries including Pharmaceutical, Biotech, Research & Development, Blood, Medical Device, and associated equipment and system suppliers.

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Datod Consulting

Datod provides process improvement and change management consultancy to small to medium-sized organizations helping them unravel complexity from their organizations. Particular focus on improving Quality Management Systems to improve efficiency, effectiveness, and compliance.

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Guide Consulting

Established to support small to medium-sized businesses with developing and maintaining their management system. Services include ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 22301, and ISO 13485.

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Commala specializes in the development of medical devices and combination products, including planning, project managing, design history file compilation, and safety risk management. More than 13 years of experience in Pharmaceutical Medical Device and Combination Product development.

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The Electrospinning Company

Electrospinning supports the development of electrospun medical devices from concept or prototype to the market with over 30 years of combined experience in biomedical electrospinning.

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Recommended Reading: How To Choose the Right Consultant for Your Medical Device

Here are the lists of Medical Device consultancies that provide their solutions primarily in other countries, such as: