The medical device industry is dominated by start-ups and small and medium-sized enterprises (SMBs) that are innovating rapidly. Furthermore, continued technological improvements in artificial intelligence (AI) and data science are helping pharma and medtech companies to build better products, advance diagnoses and treatments, and improve patient outcomes.

Medical device consulting firms typically offer regulatory and compliance guidance to various healthcare manufacturers, assisting them in all phases of device and combination product development, approval processes and post-marketing strategies.

Medical device consulting services include, but are not limited to:

  • System implementation
  • Training
  • Licensing
  • Regulatory approvals
  • Certifications

Medical device consultants

Medical device consultants work either independently or as part of a consulting firm. They advise and assist healthcare manufacturers in a range of areas to bring a medical device to the market, from conceptualisation to execution, through research, product design and development, branding, legal counsel, and audits.

Medical device regulatory consulting services specifically focus on helping manufacturers choose the best option for regulatory compliance, thereby improving the quality of core processes and creating lifelong value.

Medical device consultants offer a range of services including:

  • Optimising medical device design and development
  • Analysing clinical trial data
  • Writing clinical trial protocols
  • Writing grant proposals to investors
  • Preparing submissions for regulatory approvals
  • Handling research of relevant literature for product development
  • Advising the best path for compliance, depending on device classification, intended use, and therapeutic area
  • Working with marketing and communication teams to publicise the product through blogs, press releases, white papers and website content