Process development requires that we decide what is a "good" process for the company (and any applicable regulatory agencies) and then flesh them out and document them. They must be practical and add value to the company to be effective. This task includes documenting both world-class processes and methods to make your company more effective.
Product development is a key process that is often assumed to be perfect, but is often at too high a level or misunderstood, especially by new team members.
The medical device busness has special requirements. It requires that a company establish a quality system, including product realization processes, regulatory processes and risk management processes. Compliance auditing, both internal and by external agencies, is required.
Knowledge management includes managing intellectual property, including trade secrets, trademarks and patents, both in the U.S. as well as internationally. In addition, many companies discover a need to capture, organize and disseminate key knowledge across the team and company.