Understanding MedTech Design Controls

In this Issue

From the Editor ????| In-Brief?? |?Featured Posts ???| Sections ? | Postscript ??

From the Editor????

So many great posts this week!

This week's issue features?17 super-useful new LinkedIn posts, including a special update on?Design Controls with perspectives by Mike B. Wetherington and Vivek Thakkar .

Plus,?another fantastic weekly?Regulatory Roundup?by?Martin King .

First, a word from our sponsor,?Innolitics

In Brief ??

• Bridging device-makers and regulators : Insights spanning EU, Swiss, and UK by Miki Melech
• Avoiding the common pitfalls Clinical Evaluation Reports (CER) by Madison Hedrick, MA
• A deep dive into the 510(k) Third-Party Review Program by Etienne Nichols
• Healthcare AI risks and the SaaS vs. SaMD debate unraveled by Morgan Jeffries
• Beat Keller looks at why FMEA isn't synonymous with risk analysis
• Recent OST reorganization in the US FDA explored by Eric Henry
• ?? Unlocking design controls in MedTech , a revealing analysis by Mike B. Wetherington
• ?? Vivek Thakkar explains Why "Design Controls" shouldn’t intimidate software developers
• The dynamics of software requirements rollbacks decoded by Christian Kaestner
• Trending Flowchart: Article 120 made comprehensible , posted by Stefano Bolletta
• What defines a competent quality assurance resource? Insights from Harsh Thakkar
• Lesley Worthington challenges some of the common misconceptions and myths about Quality
• Tim Marjenin shared the newly published Tips for Submitting Comments on CDRH Guidance Documents
• Traceability in medical processes under the microscope by Andreas Kalchschmid-Lehmann
• An engaging poll about health tech product risk and funding presented by Tim Fitzpatrick
• In the regulatory maze of medical devices with Valerie Schaeffer, PhD, NREMT-P connects the dots
• Stéphan Toupin shared a chart of the steep increases in FDA device establishment registration fees

Featured Posts ??

The "Super Power" of Design Controls

As a recent post by Mike B. Wetherington explains, design controls are the key to successful medical device development. He said design controls centralize a patient-centric approach , harmonize regulatory requirements, guarantee quality and safety, and promote traceability.

Design controls also foster cross-functional collaboration, meticulous risk management, and establish global credibility, positioning products at the intersection of innovation and patient welfare.

Design Controls: A Structured Pathway to Success

Design Controls are often perceived as bureaucratic constraints by Software as Medical Device (SaMD) developers play a crucial role in FDA regulations. According to a recent post by Vivek Thakkar , contrary to stifling creativity, they provide a structured pathway to validate medical claims, ensuring patient safety and device efficacy.

Embracing these controls enhances transparency, ensures regulatory compliance, and optimizes software for clinical integration. The goal isn't to limit design but to guarantee its appropriateness for end-users.

Sections ?

??Weekly Regulatory Roundup

By?Martin King , August 14, 2023

In This Week's Regulatory Roundup

???New updates ?from?the?Egyptian Drug Authority, Swissmedic, Ministry of Health Sciences Authority Singapore, International Electrotechnical Commission, US FDA, Therapeutic Goods Administration, Australia, Ministry of Food & Drug Safety Korea, Ministry of Health Türkiye, European Medicines Agency, and British Standards Institute (BSI).

Postscript ??

Do you have an eBook, course, or webinar in you that you'd like to promote? If so, let's work together.

Sean ??