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Regulatory Affairs Medical Devices and In Vitro Diagnostic Devices

The pathway from design to commercialisation for new medical devices and in vitro diagnostic devices 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 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, Canada, EU, UK, PMDA and international regulatory agencies efficiently and effectively.

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Navigating FDA Medical Device Regulations

Episode 1: Warning letters and recalls

Hear our Medical Device experts explore FDA warning letters, recalls and the benefits of early clinical and regulatory engagement in this informative podcast. We break down differences between a form 483 and a warning letter, how to prevent a warning letter, potential recall scenarios, and how to develop a culture of compliance. Tune in to avoid compliance pitfalls and stay ahead of the regulatory curve.

Regulatory strategy

A well-crafted regulatory strategy considers applicable regulatory requirements for the markets of interest in addition to development costs, development cycles and profitability concerns. We always consider the current regulatory environment, relevant laws/ regulations/ guidance and ongoing initiatives that could influence your regulatory pathway.

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

  • Device description and specifications
  • Intended clinical application(s)
  • Labelling claims
  • Available preclinical and clinical information
  • Software and cybersecurity documentation
  • Literature references

We review and identify possible predicate devices, standard methods, procedures and/or practices, guidance documents, and other applicable regulations and policies. Using this information, our subject matter experts recommend the path to market in the markets of interest and outline the required technical information and preclinical and clinical information needed.

EU MDR and IVDR Insights

ÃÛÌÒ´«Ã½'s experienced Medical Device & Diagnostic Research regulatory team regularly share their insights in industry publications and through ÃÛÌÒ´«Ã½ produced content in the form of blogs and whitepapers. Read more content from our experts.

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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, UK, Canada and around the globe.

We work with your team to review, prepare and submit a ¡°reviewer-friendly¡± document, designed to effectively address regulatory concerns and minimize additional questions. Our experts have prepared and submitted more than 600 successful medical device regulatory documents for US and international clients, including:

  • Pre-submission support documents
  • 510(k) Premarket Notifications
  • Investigational Device Exemption Applications (IDEs), Clinical Trial Authorisations (CTAs), Investigational Testing Authorisations (ITAs)
  • De Novo Classification Requests
  • Premarket Approval Applications (PMAs)
  • 513(g) Requests for Classification
  • Technical Documentation for CE and UKCA Mark
  • Canadian License Applications

Regulatory agent/ representation

ÃÛÌÒ´«Ã½ provides 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 Authorised Representative for CE Marked devices
  • Legal Representative for Medical Device Trials in EU and UK

Download our In-country representation factsheet .

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