Knowledge Center

Engineered Success: The Engineer’s Contributions to FDA Medical Device Market Approval

In this white paper, we outline an FDA regulatory pathway a medical device might follow on its road to commercialization in the United States… but with a slightly different twist. The contributions engineers make to this industry are both critical and substantial, and they should be considered throughout the regulatory approval process.

In this paper you will learn about:

  • The role engineers play in the commercialization process
  • The value of getting a practical handle on 21 CFR Part 820
  • The importance of managing documentation early on

Thinking of the commercialization strategy from concept through completion will enable you to develop processes that will bring your product to market faster, easier and quite possibly more affordably… allowing you to move on to your next brilliant idea! So, if you’re looking to be competitive in a global marketplace… this article is a must read!

Understanding IEC 62304

What do hospital beds, blood pressure cuffs, dosimeters, and pacemakers all have in common? They are all medical devices with software that regulates their functionality in a way that contributes to Basic Safety or Essential Performance. With the FDA reporting that the rate of medical device recalls between 2002 and 2012 increased by 100% – where software design failures are the most common reason for the recalls – it’s no wonder IEC 62304 has been implemented. Its implementation, however, has medical device manufacturers asking questions about if, when and under what circumstances the standard is required.

This article explains

  • what IEC 62304 is
  • when medical devices must comply with it
  • how IEC 62304 compliance is assessed

Achieve Success with EU Medical Device Commercialization

Whether you are a US company bringing your medical device to market in the European Union, or an EU company commercializing a new product, the regulatory route for medical device approval in the European Union is very manageable – given the right knowledge and tools.

In the article, you’ll learn about:

  • EU Medical Device Classification
  • Required documentation for commercialization
  • Tips on choosing a Notified Body
  • The importance of Risk Management and Safety TestingHow to properly position your business as a true medical device company

Take a smoother path to commercialization in the European Union…

Tips for Medical Device Commercialization

Industry insider and president of MethodSense, Russ King, gives advice about commercializing your medical device, managing your regulatory affairs and developing your quality management system. Download King’s article, recently published in MEDS Magazine, More than Design: Tips for Successful Medical Device Development to learn more.

In the article, you’ll discover:

  • How to properly position your business as a true medical device company
  • The value of early adoption of 21 CFR Part 820
  • How software validation benefits not only your product, but your company’s processes long term

Save time and money when you take a smoother path to medical device commercialization!

Cloud Vendor Selection for your Life Science Company

This white paper explores how to mitigate common risks Life Science companies encounter when selecting a Cloud Vendor. By learning how to mitigate Cloud Vendor selection risks, you will be positioned to enjoy the cost savings and operational benefits of Cloud Computing.

Bringing the Cloud Down to Earth

While Cloud computing brings many advantages, it’s critical that Life Science companies understand some common misconceptions of the cloud before adopting it as a new technology strategy. This article addresses these myths to protect businesses considering a move to the cloud.

How Risky is Risk for FDA Regulated Companies?

Should the very nature of “risk” in and of itself really matter to life science companies on a level beyond scenarios of potential harm, SOP creation and record generation?

The US FDA in Perspective: It’s Never Too Early to Plan

Early stage company advice from nearly 50 combined years of experience in the life science industry.

Three Tips for Managing Your Life Science Software

Software in the life science industry has not been is more closely regulated than ever. Now is the time to revisit your life science company’s management of software to assess and remediate potential risks.

“SPIRIT” V. “LETTER” of FDA Regulations: Balance is the Key to Compliance

Separately, strictly following the “letter” or the “spirit” of the regulations can be problematic. Put them together in a contractual environment and the risk of conflict increases.

Practical Validation Tips for SAS Used in Clinical Trials

What does a reasonable and responsible SAS Validation Project look like?

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