Optimise approval: essential regulatory strategies for high-risk medical devices

Published: 14-Feb-2025 Featured companies: NSF
Regulatory

Exploring strategic approaches to navigating the FDA and EU MDR requirements while providing actionable insights for harmonising efforts across these and other regions

The development and approval of high-risk medical devices represent some of the most complex challenges in the medical device industry. For manufacturers, aligning regulatory pathways across global markets can mean the difference between a delayed market entry and a successful approval process.

This article explores strategic approaches for navigating the requirements of the United States Food and Drug Administration (FDA) and the European Union (EU) Medical Device Regulation (MDR) while providing actionable insights for harmonizing efforts across these and other regions.

Click here to find out more about essential regulatory strategies for high-risk medical devices

Featured companies

Founded in 1944, NSF’s mission is to protect and improve global human health. NSF, Pharmaceutical Services provides a comprehensive range of independent, third-party...
See more

You may also like

Regulatory

Executing a successful remediation program: part 1 of 3

Read more
This 3-part series looks at what companies need to do to ensure that they have a successful remediation program

Trending Articles

  1. You need to be a subscriber to read this article.
    Click here to find out more.
    Forecasting the future of peptide manufacturing: CMC challenges in the GLP-1 era In this article, Torsten Wöhr, Chief Commercial Officer at Bachem, explores the future of peptide CMC manufacturing for GLP-1 therapies, including innovations in sustainable peptide production, purification and compliance
  2. The right validation model: practical considerations and applications It is widely accepted that validation in the life sciences industry follows a lifecycle model (1,2). What is not always clear is the specific model — or models — to follow and how to navigate through them in the real world. Hurdles to overcome include the specific deliverables that make up that model and how they change during the various interactions along the validation journey
  3. You need to be a subscriber to read this article.
    Click here to find out more.
    Extractables and leachables: avoiding compliance bottlenecks to meet regulatory expectations As single-use systems (SUSs) transform the pharmaceutical manufacturing landscape, their growing prevalence has introduced unprecedented opportunities and challenges
  4. Innovative adhesive solution for hygienic, safe and clean bonded packaging Henkel's Technomelt Supra PRO 301 Plus bonds at the high speed of the pharmaceutical industry
  5. AskBio's Parkinson's gene therapy, AB-1005, receives FDA RMAT designation The Bayer subsidiary is currently recruiting for the Phase II REGENERATE-PD trial, which will assess AB-1005's potential in slowing Parkinson's disease progression and improving motor outcomes

Relevant companies

See more

Upcoming event

Interphex

1–3 April 2025 | Conference and Exhibition | New York, US See all

You may also like

Regulatory

Executing a successful remediation program: part 1 of 3

This 3-part series looks at what companies need to do to ensure that they have a successful remediation program
Manufacturing

Top 5 technical documentation challenges for medical device manufacturers and their solutions

Learn about the top technical documentation challenges identified through NSF's extensive experience and how to overcome them. From addressing cybersecurity risks to streamlining clinical evaluations
Regulatory

Successful preparation for a regulatory inspection: what you need to know

Regulatory inspections can be a source of anxiety and uncertainty for many organisations. However, with the right knowledge and preparation, inspections can also be an opportunity to strengthen your operations, demonstrate your commitment to compliance and quality, and identify opportunities for continuous improvement
Training & Education

Driving growth: the power of outsourcing internal audits in life sciences

In the highly regulated life sciences industry, internal audits play a crucial role in ensuring compliance with various standards, and regulations. However, internal audits can be complex, and require specialised expertise and significant time and resources
Regulatory

Why mock inspections are an essential tool for pharma leaders

Is your company ready for its next regulatory inspection? NSF's specialists can conduct a thorough pre-inspection audit to help you identify areas for improvement and ensure you meet all necessary compliance standards
Regulatory

What is NSF’s Quality Management Maturity (QMM) assessment model?

It is well recognised that the Quality Management System (QMS) - whether documentation, deviation, event management or CAPA – is the focus of Regulatory Inspections and indeed the cause of many findings. Given that the requirements have been broadly the same for so long, why is this still an area of non-compliance?
Regulatory

NSF International launches two water fitting accreditations

New REG4 Accreditations to Help Water Fittings Suppliers Rapidly Deliver Products to Market
Subscribe now