Regulatory Strategy

When a company is designing a medical device, a regulatory strategy should be developed. If a regulatory strategy is developed early in the design process, the necessary supporting documentation can be created over the course of continued development. This ensures that the company has what is needed to move forward with regulatory efforts when the design is completed. FDA compliance and/or clearance can thus be achieved with greater ease.

Regulatory strategy encompasses a broad range of activities, some related to regulatory requirements, some related to good business practices, and some involving both regulatory requirements and good business practices. Regulatory Strategy can be subdivided into the following stages: preliminary activities, pre-market, product launch, preparation, and post-market. Services that KBC has provided in each stage are highlighted in the expandable list on this page.

Preliminary Activities   +

  • Regulatory Research
  • Allowable Medical Claims
  • Applicable FDA Regulations
  • Quality System Review
  • QMS Gap Audits
  • Development of FDA Strategy
  • Development of Business Regulatory Strategy
  • Investor Liaison and Communications

Pre-Market   +

  • Trade Show Strategy and Labeling
  • Investigational Device Exemptions (IDE)

Preparation   +

  • Packaging and Materials
  • Testing and Validations
  • 510(k) Submission
  • Quality System Creation / Improvement
  • Training and Mentoring of Staff

Product Launch   +

  • 510(k) Clearance
  • FDA Establishment Registration
  • Device Listing
  • Label and Import Issues

Post-Market   +

  • FDA Inspections
  • Device and Label Changes
  • Service and Repair
  • Recalls and Upgrades
  • Resolve FDA Problems