Your industry is highly competitive, and your products are literally changing lives. Getting your medical devices to market quickly has to be a top priority.

But making it through audits and passing all of the required FDA or ISO regulations is time-consuming and frustrating.

How can you focus on what really matters — launching your product — when you have so much red tape to fight through?

Partnering with an experienced advisor can help you pass audits to get the regulatory stamp of approval with much less hassle than if you did it on your own. We'll show you six of the best medical device regulatory consulting services in the life sciences industry and dig into why we recommend each one so you can find the right fit for you.

6 of the Best Medical Device Regulatory Consulting Services

Most regulatory consultants are brought in to help a company like yours at one of two key times in the product's lifecycle.

Medical device consulting contractors are typically hired after the company has failed an audit and realized they need help if they're going to get to market soon. Smart companies, however, hire FDA and ISO consultants before they run into trouble to ensure their quality systems are set up correctly from the beginning.

If you recognize early on that you will benefit from outside support, you will avoid many unnecessary headaches as you're creating your product. New call-to-action

Note: The firms below are well-respected in the medical device community, but you should do your own due diligence before selecting a partner.

Talk to past customers, ask for case studies, and verify the consultant's work record and capabilities. These specialists should be willing to provide examples of their impact on similar projects.

As a leading eQMS provider in the life sciences industry for medical device companies with 5-500 employees, we've worked with some of the best consultants around. We'd be glad to share some of our experiences with these quality experts with you. Feel free to contact us.

Related Reading: What to Look for in Quality Management Consulting Services

1. MWA Consulting, Inc.

MWA strives to be the leader in GXP compliance consulting for pharmaceutical, biotech, and medical device industries. Their services include GCP, GLP, and GMP compliance through the full product lifecycle — from development through to commercialization.

They also provide training and workshops in addition to their consulting services for FDA compliance and clinical improvement.

MWA's Expertise Includes:

  • Performing internal and external audits for GMP, QSR, GLP, and GCP in the U.S., Canada, Europe, Asia, and South America
  • Clinical Quality Assurance (CQA) programs and infrastructure for compliance including audits, clinical trial design, mock regulatory inspections and training, development, implementation, pharmacovigilance support, clinical project management, GCP training, and virtual clinical QA services.
  • FDA compliance strategies that include developing and implementing successful GXP quality systems and compliance strategies.
  • Standardized and customized training on a wide variety of GXP topics that are designed to reflect current regulatory standards across more than 21 topics.
  • Regularly hosted workshops and webinars.

2. M Squared Associates

M Squared's mission is to provide a full range of quality, regulatory, and clinical consulting services to both international and U.S. medical technology companies. They specialize in working with firms that are producing devices and combination products that will be reviewed by the FDA's Center for Devices and Radiological Health (CDRH).

M Squared's Expertise Includes:

  • Designing and implementing quality management systems (QMS) that are in compliance with 21 CFR Part 820 and ISO 13485.
  • Offering full-service CRO capabilities within budget and timeline requirements for small feasibility studies, usability studies, marketing studies, clinical performance, and multicenter pivotal studies that support PMAs.
  • Clinical trial support in the U.S. and internationally through clinical sites in the U.S., Canada, Mexico, Brazil, and the EU.
  • Preparing technical files for application for CE Marking and Health Canada Medical Device License.
  • Experience preparing 510(k)s, PMAs, IDEs, De Novo Petitions (de novo 510(k)s), industry-sponsored and FDA-sponsored reclassification petitions, and Humanitarian Device Exception (HDE).

3. MDI Consultants

MDI strives to be a leader in providing quality management consulting services worldwide to the healthcare industry. They have experience working with medical device, biotechnology, pharmaceutical, and food companies. MDI helps their clients achieve compliance in the U.S., Canada, and European regions.

MDI's Expertise Includes:

  • Clinical trial management services that include the development of clinical protocol, interacting with the Institutional Review Board (IRB), submitting your Investigational Device Exception (IDE), working with your investigator, trial monitoring, data analysis, project management, and statistical analysis.
  • FDA and ISO compliance consulting services for medical devices, pharmaceuticals, and foods.
  • Crisis intervention for FDA 483 and FDA audits.
  • Assistance in applying for and receiving your CE mark, including device classification, technical file preparation, selection of your certifying body, and assistance with your "responsible person."

RELATED READING: Why Did Medical Device FDA 483 Observations Drop 6.2% Last Year?

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4. Ken Block Consulting

Ken Block Consulting focuses on helping companies produce safe and effective medical devices for both U.S. and international markets. Their services cover all areas of FDA regulations that are responsible for governing the production and distribution of medical devices.

Ken Block's Expertise Includes:

  • Developing FDA regulatory compliance strategies across the full lifecycle of product development, including preliminary activities, pre-market, launch, preparation, and post-market.
  • FDA submissions including 510(k), PMA, and de novo submissions in addition to Pre-Subs, IDE, HUD, and Master Files.
  • FDA 21 CFR Part 820 and ISO 13485 compliant Quality System Regulation in the U.S., Canada, Europe, and Australia.
  • Creating and reviewing validation documentation for a wide range of medical device manufacturers to meet both FDA and ISO guidelines.

5. Smith Associates

Smith Associates specializes in regulatory consulting services for companies that manufacture medical devices, in vitro diagnostics, blood, and biologics — including 510(k) submissions, pre-submissions, Pre-IDE, PMA, and Human Factors studies.

Smith Associates' Expertise Includes:

  • Regulatory services such as 510(k) premarket notification, pre-submission, investigational device exceptions, PMA, U.S. Agent services, and initial importer.
  • Implementation-ready Part 820 Quality Systems with the SOPs and supporting logs and forms.
  • Quality system audits, 483 Observations, warning letter responses, recalls, and corrections.

6. The Weinberg Group

The Weinberg Group has over 35 years of experience in regulatory consulting for biotechnical, medical device, and pharmaceutical companies across the globe. They aim to provide their clients with unparalleled scientific knowledge in the areas of FDA and global regulatory affairs.

The Weinberg Group's Expertise Includes:

  • Project-based regulatory strategy and submission to help you plan your regulatory milestones and possible challenges.
  • FDA consulting for compliance issues that includes Good Clinical Practice (GCP) Audits, Good Manufacturing Practice (GMP) Services, Quality Systems, and Quality Management.
  • Development of Abbreviated New Drug Application (ANDA) filing plans, submissions, and all relevant modules.

Improving Medical Device Quality

Choosing the right consultant can be difficult. There are so many factors that can make your relationship with them succeed or fail.

Start by understanding what factors define a great consulting engagement and learn how to evaluate a firm's relevant experience and knowledge of your products and systems.

If you'd like to dig deeper on the subject of evaluating the services above, check out What to Look for in Quality Management Consulting Services.

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Published by Robert Fenton September 12, 2019
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