Vista Regulatory Solutions (VRS) specializes in Quality System Management and Regulatory Affairs for start-up to mid-size medical device companies. Our in-depth services and expertise can help you to get your product to market faster, and keep it on the market.

Quality Systems

VRS specializes in developing your Quality Management System (QMS) to ensure you meet global regulatory requirements and meet your objectives. We do this using a pragmatic approach to systems development that adds value to your business and customers. Whether you need to develop a new system or modify existing systems to improve processes, we can help.

There are several changes to QMS requirements currently underway that will impact most medical device organizations. Updates to ISO 13485, European Medical Device Regulations and the Medical Device Single Audit Program (MDSAP) just to name a few. We are constantly monitoring QMS Regulation changes and can assist you in understanding the impact to your organization and make sure you meet critical deadlines.

Quality Systems Services & Expertise

  • FDA QSR – 21 CFR Part 820
  • Canadian Medical Device Regulations
  • ISO 13485: 2016
  • EU Medical Devices Regulation (MDR 2017/745)
  • Medical Device Single Audit Program (MDSAP)
  • Internal and Supplier Audits, Gap Analysis and Assessments
  • Process Development and Implementation
  • FDA and Notified Body Inspection Support
  • SOP Development and Training
  • Internal Auditor Training
  • Sterilization Validation
  • Risk Analysis, ISO 14971

Regulatory Affairs

VRS has in-depth knowledge of the global regulations, standards, product submissions and applications needed to ensure that your company and products meet relevant compliance requirements. We will provide you with the confidence that your medical products are available where and when your customers need them. From start-up to mid-size organizations, we can help you get your medical device to market, and provide support to maintain ongoing requirements for post-market activities.

Regulatory Affairs Services & Expertise

  • Regulatory Planning and Strategy Development
  • Regulatory Compliance
  • Global Regulatory Submissions
  • Regulatory and Quality System Due Diligence
  • FDA QSR/cGMP, MDD, CE Mark
  • EU Medical Devices Regulation (MDR 2017/745)
  • Technical File and Design Dossier Compilation and Review for CE Marking
  • FDA Pre-Submission Meetings – Manage or Assist with Preparation and Conduct of FDA Agency Meetings
  • Medical Device Reporting (MDR) and Vigilance Reporting
  • Labelling and Advertising Review
  • FDA U.S. Agent Services
  • Establishment Registration and Device Listing
  • Master Files
  • Response to FDA Form 483 and Warning Letters
  • Product Recall Assistance

Interested in learning more about how Vista Regulatory Solutions can help your company with their Quality Systems or Regulatory Affairs? Contact Us today.