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Every technology and product sold in the US and any of the major markets around the world requires regulatory clearance by the respective government agency.  The regulatory requirements are constantly changing and becoming more complex.  With decades of experience working both on the sponsor side and for the FDA (at different time periods), we understand how to navigate this environment.  We also understand the implications of the regulatory requirements on product design, marketing plans, reimbursement, competitiveness and market acceptance.

 

Understanding the intricacies of such issues and developing appropriate plans can spell the difference between success and failure for projects and investments.  Selecting less than optimal strategy can be prohibitively expensive, extend time-to-market and slow down sales for otherwise, promising products.

 

Boston MedTech Advisors can assist medical technology companies, inventors and investors in addressing these critical issues by:

  • Reviewing FDA and other pertinent regulatory guidelines

  • Incorporating the regulatory and clinical testing requirements into the product development process

  • Identifying sites and principal investigators for clinical studies

  • Developing clinical study protocols in support of regulatory submissions, marketing and reimbursement activities

  • Providing technical, clinical and management oversight during clinical studies

  • Preparing regulatory filing plans, 510(k), PMA and IDE applications

  • Conducting meetings with the FDA and other regulatory agencies

  • Evaluating the regulatory impact on marketing campaigns

For examples of our team's extensive experience in this area, which includes planning and actual submissions of regulatory filings covering many medical disciplines, select Experience.

 

LILIS™ (Laser and Intense Light Information Service) helps laser and intense light manufacturers, distributors, clinicians and aesthetic service providers navigate the complex maze of state and federal regulations.  LILIS™ provides regulatory information through phone support and written reports.

 

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