Medical Device & IVD

Regulatory Consulting for Medical Device & IVD

The pathway from design to commercialization for a new medical device or IVD can be unclear and complex. Regulations and requirements vary by country, level of risk, specific product claims and intended use. Our medical device & IVD regulatory experts can help you gain a deep understanding of the applicable regulations and requirements, often beyond what is available in published guidance documents and other materials.

We will work with you to design and implement a competitive and cost-effective regulatory strategy, prepare and submit a “reviewer-friendly” marketing application, and serve as your liaison from start to end, helping you to negotiate with FDA, EU, and international regulatory agencies quickly and effectively.

Regulatory Strategy

A well-crafted regulatory strategy considers not only international and FDA medical device regulations, but also development costs, development cycles, and profitability concerns. Aptiv Solutions will consider the current regulatory environment, relevant guidelines, and ongoing FDA and/or international medical device initiatives that could influence your regulatory pathway.

Our regulatory experts are well-respected by the FDA and international agencies, and have excellent rapport with agency leaders and reviewers, earned through years of professional experience and almost daily interactions. Our medical device regulatory experts will consider information about your medical device, including:

  • device description and specifications
  • intended clinical application(s)
  • labeling claims
  • available test data
  • literature references.

We will review and identify possible predicate devices, standard methods, procedures and/or practices, FDA submission guidance documents, and other applicable regulations and policies.

Submission Management

Depending upon the classification of your medical device and your current stage of development , there are a variety of submissions that may be required by medical device regulatory agencies in the US, Europe, Canada, and around the globe.

Aptiv Solutions will work with your team to review, prepare and submit a “reviewer-friendly” document, designed to effectively address FDA and ROW regulatory concerns and minimize additional questions. Our experts have prepared and submitted more than 600 hundred successful medical device regulatory documents for U.S. and international clients, including:

  • Pre-submission / Pre-IDE Meeting support documents
  • 510(k) Premarket Notifications
  • Investigational Device Exemption Applications (IDEs)
  • Premarket Approval Applications (PMAs)
  • Investigational New Drug Applications (INDs)
  • 513(g) Requests for Classification
  • Biologic License Applications (BLA)
  • Technical Files / Design Dossiers for CE Mark
  • Canadian License Applications

Regulatory Agent / Representation

Aptiv Solutions can provide clients with the necessary representation to cover a range of regulatory activities:

  • FDA Establishment Registration / Device Listing activities
  • FDA US Agent for Foreign Establishments
  • EU Authorized Representative for CE Marked devices
  • Authorized Representative for Medical Device Trials in Europe