Preventing and Managing Disruptive Compliance Challenges

By Carl Manthe, Director and Medical Technology Industry Lead, Integrated Project Management Company, Inc. We all have limited time and resources, both in our personal…

“How can we submit sooner?” It’s long been the most common question a regulatory submissions team hears. Executive leaders have ambitious goals in mind for…

Medical device and diagnostics companies found out the hard way that complying with the European Union In Vitro Diagnostic Regulation (IVDR) is more challenging than…

Some good news: In March, final product safety certification deadlines were extended until 2027 or 2028 depending on the device class for European Union Medical…

Even when a company is first to market with a groundbreaking medical device, product development doesn’t end. Medical staff, patients, and repair technicians—even payers—want it…

Breaking up is hard to do. We’re not talking about broken hearts but company divestitures. When a company carves out part of its business, the…

Drug discovery, development, and commercialization is like a puzzle. The end may be easy to visualize, but there are many pieces that need to be…

There’s an adage that says what gets measured gets improved. Regulatory submissions are no exception. And with the growing complexity of clinical trials and increasing…

Companies often begin achieving some business benefits of a merger or acquisition as soon as the two entities become one. And forward-looking organizations are eager…