Is your medical device company facing an uphill battle with the FDA? Are you struggling to pass an audit and get ISO-certified quickly? The best medical device consulting services will help you achieve compliance, obtain certification, and take safe, effective products to market.
Carilex Medical, Inc. needed help achieving Medical Device Single Audit Program (MDSAP) certification to satisfy regulatory requirements in multiple global jurisdictions. They looked to MDI Consultants for expert support with this complex project.
"Success is only possible with in-depth understanding of all MDSAP requirements and their complete implementation,” says Carilex Medical President Elliot Goldsberg. “The MDI Consultant team worked closely with our staff throughout the entire process providing stable and consistent support.”
Hiring an experienced medical device consulting service can streamline even the most complicated projects or help remediate challenging regulatory issues. To help you find the expertise you need, we’ll share a visual breakdown of the services offered by some leading medical device consulting services.
The Offerings of 6 of the Best Medical Device Consulting Services
There are countless reasons medical device manufacturers turn to a quality management consulting service for help. Consultants are commonly called in to address compliance challenges, validate projects, or complete applications for device approval. Sometimes, consultants assist with creating a regulatory strategy, implement a quality management system, or even provide long-term expert support.
Each of the six medical device consulting services included in this list has extensive experience working with FDA-regulated firms in the life sciences industry. However, they offer slightly varying specialties and expertise. The following table can serve as a quick guide to understanding the strengths of the leading device consulting services.
Please note this chart may not be a fully comprehensive reflection of consultant offerings. Services and experience are subject to change. Use this table to narrow your search based on your project needs, and inquire directly with prospective consulting service firms to learn more.
You can also fast-track your way to multinational compliance and a quality-driven culture with Qualio’s cloud-based enterprise quality management system (eQMS). As the first eQMS built specifically in accordance with FDA and ISO guidance for device manufacturers, Qualio offers an industry-leading 60-day implementation timeline and concierge onboarding for medical device manufacturers with 5-500 employees. Learn more about our flexible cloud eQMS software.
The Weinberg Group is an FDA-specialized consultancy with vertical expertise in life sciences industries. This consultancy specializes in pre-clinical and pre-regulatory consulting services, including medical device submissions and meetings. The Weinberg Group was acquired by ProPharma in January 2019 and intends to expand service offerings to support global clients in all stages of product development.
Ken Block offers a wide array of regulatory and quality consulting services for medical device manufacturers at every stage of the product life cycle, including strategy and support for international regulatory requirements. This multinational consulting firm has offices in the US, France, and Japan.
MDI provides a broad range of consulting services for the medical device industry, including quality assurance and clinical trials. Founded in 1978, MDI Consultants has an extensive track record of successfully supporting clients through regulatory remediation projects. This Great Neck, NY-based firm offers several relatively unique specialties, including emergency “FDA Crisis Intervention” and authorized import agent services.
M Squared Associates offers “FDA regulatory and clinical services,” specifically for medical technology clients. The agency works with device manufacturers to implement FDA and ISO 13485-compliant quality systems, perform audits, and respond to FDA warnings and letters. M Squared is a full-service clinical research organization with international experience. This consultancy has locations in New York, NY and Alexandria, VA.
Formerly known as Marion Weinreb & Associates, MWA is a quality systems and GXP consultancy for companies in the life sciences industries. They offer a broad range of regulatory support for device manufacturers “from development through commercialization,” including facility validation, deviation investigations, and quality systems support. This small consultancy is based in Hillsborough, CA.
Further reading: The Pros and Cons of Medical Device Consulting
Emergo is specialized in global compliance for the medical device and in-vitro diagnostics industries, with “comprehensive offerings” for the total product lifecycle. Their services include support for product design, market access, multinational regulatory approval, and clinical research projects. Emergo offers unique services for device cybersecurity risk consulting and business process improvement. Headquartered in Austin, TX, Emergo has over 20 physical locations on six continents worldwide.
Picking the Right Medical Device Consultant for You
The right consultant can help your organization bring safe and effective devices to market by creating a regulatory strategy, performing clinical trials, or helping your organization achieve ISO or MDSAP certification. Understanding the strengths of each consulting firm can be a helpful tool to narrow your search for an expert.
Evaluate a prospective consultant’s experience based on their record of success, cost, and potential cultural fit. Ask for references and case studies to verify experience working with similarly sized clients. Finally, ask your QMS vendor for recommendations of a trusted consultancy who knows how to use your quality management software.
Feel free to reach out to our team for a recommendation here.