Regulatory

Daunted by the regulation of medical device manufacturing?

As ISO 13485 certified consultants, we’ve navigated the regulatory waters and are ready to guide your safe passage. We align your product goals with design controls and documentation standards defined by key medical device certifications. From regulatory applications to on-going compliance review, we ensure that you arrive on the market with a high quality, audit-ready product.

planning

Despite the cliché, the best laid plans tend to yield quality results.

development

Optimize product form and function for rapid market acceptance.

regulatory

Enter the market with a high quality, audit-ready product.

manufacturing

Scalable, customized and comprehensive manufacturing.

define, document and control… repeat.

  • Our Quality Management System provides full transparency and allows our customers to remotely leverage our system and expertise.
  • Pathway sets a strategy to align your product with ISO 13485 design control and documentation standards.
  • From regulatory application through 510(k) regulatory clearance, we will sweat the details to ensure that your project is in full compliance and audit-ready.
  • Our post market surveillance and sustaining engineering services assure that all work is in compliance with ISO and FDA standards and documentation is kept current.

deliverables:

  • Define regulatory requirements in markets of interest
  • Regulatory Plan
  • Prepare and maintain design history files
  • Packaging and labeling designs
  • Technical file and regulatory submission
  • Support clinical trials
  • Manage electrical safety certifications
  • Technical files for CE Marking
  • FDA UDI Registration
  • Sustaining engineering