Medical device industry
Are you worried about the status of your pipeline of new products or frustrated by the ever-changing regulatory environment? Are you looking for a hands-on expert or just an informed listener to help you put your situation into perspective?
You can depend on Plante & Moran business management consultants, accountants, and tax specialists to complement, enhance, and reinforce your team. They are experts in tax planning, technical accounting, regulatory affairs, quality assurance, supply chain management, operations and business process improvement, manufacturing, validation, information technology, and human resources.
They know the medical device industry (Classes I, II, and III). You can rely on them to understand when you talk about ISO 13485 and 21 CFR Part 820. You will profit from their ability to collaborate with their 1,500 colleagues in our firm and their access to 25,000 allied business advisors around the world. If you are a company that is entering the medical device sector for the first time, you will also appreciate their first-hand knowledge of where you have been and where you want to go.
You will benefit from our hands-on knowledge
Plante & Moran business management consultants have extensive experience with medical device companies. You will benefit from this hands-on experience when it comes to important issues. To best serve you, they will draw on their experience and immerse themselves in your processes and procedures. It’s their way of investing in your success and helping you thrive. You will learn to value their ability to help you quickly turn a good idea into an approved product, produced and ready for market.
Navigating a complex regulatory environment
You can rely on our medical device industry consultants to be on top of the latest international and FDA regulations. They know that FDA citations for failing to maintain Corrective Action Preventive Action (CAPA) systems are high. And they are anticipating that supply chain issues are going to become the next big issue as the FDA responds to a rash of recalls.
Our medical device consulting team has the experience and methodologies to ensure your company complies with FDA quality standards. It’s a matter of law and in your financial interest.
Your success comes first
It is our firm philosophy to invest in the success of our clients. To us that means understanding your industry and taking a proactive approach to providing the services you need to prosper. From helping your company develop a new supply chain strategy, to providing a financial statement audit, our expert consultants have the experience to help you thrive. That is why our auditors who serve the medical device industry are sensitive to reimbursement issues, inventory management, and complex capital structures and our tax specialists are experts in research and development tax incentives and other tax minimization strategies. You can also rely on our international business advisors for help in creating a global business strategy that identifies opportunities for cost-efficient suppliers throughout the world.
We like to say “your business is our business.” You can trust us to know your business and depend on us to help you succeed.
Operations & Process Improvement
Companies and their stakeholders appreciate how they quickly can identify, quantify, and manage operational and supply chain underperformance associated with quality, cost, and delivery. Whether you need to coordinate a product transfer to a low-cost region or shut down a facility, our consultants can lead you through these activities with best-in-class execution to minimize your risk. Their services include: quality management systems, product and process transfer; facility rationalization; and tax minimization.
Our medical device team includes transaction specialists who can help you realize the full value in a merger or acquisition. From due diligence to post-acquisition integration, they can help you focus on operational and financial outcomes. You can depend on them to understand the need to reduce uncertainty in the decision making process and yet appreciate the need for speed. Our multidisciplinary team can provide due diligence on financial, strategic, operational, and technology issues; tax structuring; acquisitions and divestitures on the buy and sell side; valuation.
Financial Statement Audit
Conditions for medical device companies have changed dramatically over the last couple of years. There is increased competition, slower growth, and thinner margins. Meanwhile an aging U.S. population, access to global markets, and technology advances hold promise.
Our tax advisors who continually monitor changes in federal, international, state, and local tax policies and understand how they relate to the medical device industry can help you adjust your existing tax plan to take full advantage of opportunities to reduce your tax burden.