Regulatory Affairs

BBA offers comprehensive regulatory services to our clients to assist you in achieving global success in the product approval process as well as the post approval regulatory compliance maintenance.  Our team, led by individuals with 20+ years in the industry, has broad experience and insight in pre- and post-marketing medical product regulations and can aid you in navigating the process.

Regulatory Submission Preparation and Maintenance

The BBA Regulatory Affairs Department provides comprehensive submission preparation and maintenance support to clients at all stages of the medical product development process.  We will partner with you to understand your business objectives and market plans to define an efficient and effective regulatory strategy.  We can develop complex regulatory strategies for you or work with your team to produce a regulatory submission that enhances your chance for product clearance with a minimum review cycle.  From pre-submission meetings through panel meetings and beyond, our team is available to assist you.  We can provide you with basic regulatory guidance and submission support and the more specialized services such as interactions with the Ombudsmen related to scientific disputes and the preparation of 513 (g) Request for Designation documents.  Once marketed, we will partner with you to ensure your product clearance or approval is maintained throughout its life cycle.

Strategy

  • Strategic planning and overall regulatory guidance
  • Interactions with reviewing divisions of FDA and the Office of Ombudsmen

Submission Support

  • Interpretation of standards and guidelines
  • Development of bench testing protocols
  • Development of biocompatibility test strategies
  • Interactions with test houses
  • Validation testing guidance and interface (electrical testing, packaging, sterilization)
  • Development of animal study designs/protocols
  • Interface with GLP animal facilities

Submissions

  • U.S. Regulatory submissions
    • Pre-market notifications – 510(k)
    • Pre-market approval applications – PMA
    • Advisory Committee preparations
    • 513 (g) Request for Designations
    • Investigational device exemptions – IDE
    • Humanitarian Device Exemptions (HUD/HDE)
  • International Design Dossiers
    • EU Technical file, Design dossier and CE Mark documents
      • Individual EU country registrations
    • Health Canada applications
    • Australia/New Zealand applications
    • Latin America applications
    • Asia Pacific applications

Post Approval Compliance

  • Recall strategies
  • Warning letter mitigation and resolution
  • Medical Device reporting (US, EU, Canada, Australia) and complaint handling
  • Post-market Surveillance Reporting

International Registration

Our team has worked closely with a number of notified bodies for the European market.  We can assist you with all of the regulatory discussions and guide you through the entire regulatory process.  We consistently stay abreast of the evolving regulatory requirements by country and region so you don’t have to.  Call today to discuss your project needs.

Management of product complaints

  • Tracking/trending product complaints
  • Complaint reporting to Regulatory Bodies (US, EU, Canada, Australia)
  • CAPA initiation
  • Metrics for Management Reviews

Complaint Handling and Recalls

As an ISO 13485 certified company, BBA has established procedures and experience in complaint handling for both the premarket and post-market phases of your medical product.

Premarket Complaint Handling

During execution of your clinical trial, it is not uncommon for device observations and customer feedback to be obtained.  This information is required to be documented within your quality system to ensure your risk analysis is contemporary.  We will execute the process for you to ensure the necessary information is captured, a decision is made regarding reportability to FDA in a clinical trial setting, and partner with your Quality and R&D teams throughout the device investigation process. We manage the process and the paperwork so you don’t have to.

Post-market Complaint Handling

Timeliness is key in the complaint process once your device is on the market.  Complaint reporting is currently one of the leading causes for warning letters for medical device companies.  BBA will execute your complaint handling process; ensuring reportability decisions are documented, and if a report is required, submitted within the required timelines.  We partner with your Quality and R&D teams to provide input on device failure analysis, possible corrective or preventive actions, and customer feedback to ensure that the complaint process has been documented appropriately.  We manage the complaint files and ensure all necessary steps are documented, including communications with the physician and Regulatory Authorities (US, EU, Canada, Australia), device analysis reports, and risk management summary reports.

Field Corrective Actions/Product Recalls

When issues arise and a field corrective action is warranted, BBA has the expertise to partner with your team and help execute the prescribed field action strategy including product recall.  As part of the partnership with BBA, we can facilitate the necessary initial, follow-up, and closure reports to Regulatory Bodies (US, EU, Canada, Australia) to ensure your reporting requirements are timely and in compliance. In addition, we can assist your team to develop the appropriate corrective and preventive actions required by your Quality System.

The Boston Biomedical Associates team was instrumental in their support of AtriCure in executing our ABLATE trial, interacting with the FDA and preparing for the panel meeting. We are impressed with their extensive clinical and regulatory expertise as well as their professionalism and appreciate their support in working with us to achieve a positive panel vote.
— David J. Drachman, Former President and Chief Executive Officer of AtriCure, Inc.

To Discuss Your Regulatory Needs with a Member of the Regulatory Team

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