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Quality & Regulatory Compliance

Getting your medical device product to market can be a long and complex process. Staying current on and meeting FDA and other regulatory body requirements can be daunting for any organization. After all, you have a business to run. Our team helps you understand requirements and minimize time spent on submissions. We provide the specific expertise and support you desire, from remediation, project development management, and validation and verification to quality system compliance, audit preparedness and on-site audit support, and post-market assistance.

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Our clients say

Every organization has opportunities to do things more effectively & efficiently, but not every organization identifies those opportunities to work on that are in line with their overall strategy. In my experience with Plante Moran, they work to understand the strategy early on in any engagement in order to apply this principle to identify & assist in implementing changes to implement efficiencies & drive out costs. Before I even realized it, their influence on the organization became part of the culture; ideas were then being generated from all levels of the company. Their approach had the opposite impact on how most organizations approach to cost reduction projects & were very valuable in the long term to the health of the company. No other firm that I’ve work with has come close to their approach.

Brad Aquino Division CFO and PMI Lead, Fortune 500 Clients

Our Team

Our team not only brings specialized expertise but also serves as an extension of your in-house capabilities. Each of our professionals brings an average 25 years' industry experience, and we work closely and collaboratively with you in key areas — regulatory compliance, quality management, manufacturing, supply chain management, clinical, marketing, and R&D — to help formulate regulatory strategy and implement tactics to optimize global compliance.