Which are the top medical device consulting firms in 2020? That's a big question because the right consultant for your organization can speed up your time to market, pass regulations easily, and develop a quality-driven approach that your team can implement to lead the market.

In one consulting success story, a biotherapeutics firm had a “desperate need” for transactional accounting help while approaching an IPO. Partnering with highly specialized experts at M Squared Consulting helped the company navigate all of the intricate SEC requirements involved with interim reporting, audits, and filing. The biotech firm raised over $60 million in capital, thanks to an innovative product and a productive consulting partnership.

This case study is a clear example of why consulting firms can be a powerful asset to medical device organizations. Partnering with an expert can help you navigate significant barriers on the road to market approval. We'll show you some of the top medical device consulting firms below so that you can find the best consultant to take your company to the next level.

The 6 Top Medical Device Consulting Firms in 2020

The top medical device consulting firms in 2020 include a broad mixture of consultancies with varying specializations. The top firm for your company is likely to vary based on numerous factors, including your project goals, your company size, geography, and budget.

The wisest way to choose quality management consulting firms to interview is to understand your needs in advance. Evaluate whether you need project-based support, or if you would be better served with a long-term outsourcing agreement. Being realistic about your needs and expectations can help you narrow your options significantly to find the best firm.

1. The Weinberg Group

The Weinberg Group is a well-known “FDA consulting firm” headquartered in Washington DC with 35 years of industry experience consulting for biotech, pharma, and medical device companies. The consulting firm’s specialties include helping clients develop regulatory strategies, improve compliance, and prepare for key FDA meetings. In addition to project-based consulting, The Weinberg Group offers an “Outsourced Regulatory Affairs” (ORA) program, or the opportunity to fully outsource regulatory tasks as a professional service subscription.

In early 2019, The Weinberg Group was acquired by ProPharma Group, an 1,100-employee global provider of professional services for life sciences companies, including outsourced medical information services. New call-to-action

2. Ken Block Consulting

Ken Block is a global consulting firm specializing exclusively in the medical device sector, with offices in Paris, Tokyo, and Richardson, Texas. Founded in 2005, the company offers project-based consulting on several types of device regulations. Specialties include regulatory compliance, strategy and submissions, and marketing and labeling topics for approved devices. Other services include consulting support during device recalls and training.

RELATED READING: The Pros and Cons of Medical Device Consulting

3. MDI Consultants

MDI specializes in consulting for FDA-regulated companies in the medical device, pharma, and food industries. The company is committed to recruiting subject matter experts to provide professional services from their Great Neck, New York headquarters and 10 other locations worldwide. MDI’s offices include Los Angeles, Knoxville, and Charlotte, as well as locations in the European Union, the Asia-Pacific region, and the Middle East.

MDI has unique expertise in helping clients achieve global compliance in multiple markets, including regulatory experience with European and Canadian regulations. Their professional outsourcing options include support for regulatory affairs, audits, quality system validation, ISO certification, and numerous other areas.

4. M Squared

Founded in 1988, M Squared is a consulting firm that specializes in professional services for highly regulated industries, including FDA-regulated verticals, banking, and government agencies. The company employs 381 experts globally to provide assistance with regulatory affairs, business transformation, and execution projects in multiple industries.

M Squared’s corporate headquarters are located in Wayne, Pennsylvania. Additional locations include Boston, Houston, New York, Philadelphia, San Francisco, and the Washington DC metro area. Client case studies online showcase M Squared’s success in regulatory projects, the finance industry, and business transitions.

RELATED READING: 4 Regulations That Apply to Medical Device CRO Selection

5. MWA Consulting, Inc.

This consulting firm has a simple core focus, which is to help drive GXP compliance at biotech, device, and pharma organizations. According to MWA’s website, they employ over 300 life sciences experts worldwide to provide support in key focus areas of good clinical practice (GCP), good laboratory practices (GLP), and good manufacturing practice (GMP).

MWA Consulting’s website states they have worked with life sciences companies of all sizes. Client use cases detailed on MWA’s website include a broad mix of life sciences projects, including qualifying a biotech plant facility, providing support for a medical device 510(k) filing, and acting as a QA Director at a pharma firm.

6. Emergo

Emergo is specialized in medical device and in vitro diagnostic (IVD) compliance with global regulations, in addition to industry specialization in health retail and other life sciences projects. Their global consulting team works from over 20 office locations on six continents worldwide, including US headquarters in Austin, Texas. Emergo’s specialties for device and IVD clients include research design, market access strategy, and fully outsourced support for fast growth clients.

The Value of Medical Device Consulting Firms

There’s more than one valid reason to hire a consulting firm. Medical device companies can benefit from consultants in many different ways. The right consultant can help create a strategy, implement quality management system (QMS) software, or navigate high-stakes situations such as device filings.

Some consultancies can also offer quality management services that incorporate ongoing support and full outsourcing. Entering into a recurring agreement to outsource quality management or compliance to experts can allow medical device firms to achieve a quality-driven culture and focus on what they do best—innovation.

At Qualio, we've developed the world's leading enterprise quality management system (eQMS) for medical device companies with 5-500 employees. We've worked with several great consulting firms that know our platform, and we'd be glad to connect you with them. Just contact us, and we'll find the best fit for you.

To learn more about our eQMS, click here.


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Published by Robert Fenton January 2, 2020
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