FDA Launches Device Software Pre-certification Pilot

The FDA’s new pilot program for pre-certifying software for digital medical devices is up and running and companies can now apply to take part in the program. The goal of the new approach is to determine whether a company meets the necessary quality standard. Read More

What Device Manufacturers Can Learn From FDA’s Inspection Data

Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More

MHRA Updates Guidance on UK Notified Bodies

In a decision associated with the United Kingdom’s withdrawal from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK. Read More


China’s Medical Device Regulations - Webinar CD/Transcript

China, the hottest medical device market on the planet, is welcoming U.S. devicemakers. A push is on to streamline importation of medical devices, including letting U.S. drugmakers set up production in China and collaborate with local manufacturers. The price is a familiar one: Compliance with China’s regulations. View

Transforming the Medical Device Critical Process Supply Chain - Webinar CD/Transcript

Now, FDAnews has brought together two MedAccred thought leaders (from J&J and Stryker), plus a MedAccred suppler (Global Technologies) for presentation introducing you to this innovation in supply-chain auditing. View

Equipment Design and Qualification: A Guide for Drug and Device Manufacturers

This report — authored by international GMP expert Thomas Peither and associates — describes how to create and qualify a design plan that will meet the manufacturing goals and regulators’ expectations. View

Cybersecurity and Risk Management for Medical Devices - Webinar CD/Transcript

If your medical devices incorporate software, they may be targets for cyber-crooks. It’s time you adopted a strategy to gain information, evaluate it, and take action — including regulatory responsibilities. This FDAnews presentation provides the regulatory information you need to stay compliant. View

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls

Devicemaker Quality Compliance: Using Risk Management to Improve Design Controls shows you where design control and risk management requirements overlap so you can serve both with one integrated effort. View

Combination Products: Managing Design Controls - Webinar CD/Transcript

Planning to submit a new combination product for FDA approval? The final guidance regarding Current Good Manufacturing Practice Requirements for Combination Products — the document that may hold the key to success or failure — is a lot more nuanced than many realize. View

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View

Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line - Webinar CD/Transcript

The “CY2016 Annual FDA Medical Device Quality System Data” report is an information goldmine for devicemakers — a key to better inspection outcomes as well as greater quality in manufacturing. View

Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers

This report — authored by international GMP expert Thomas Peither and associates — lays out the basics of building a four-phase qualification plan… design qualification, installation qualification, operational qualification and performance qualification… that satisfies US and EU requirements. View

Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends

Complaint management is essential to a functioning quality management system. Understanding the FDA’s Quality System Regulation isn’t enough — you must also master ISO 13485:2016 and the new EU MDR. They all require devicemakers to conduct trending in some form or another. But none of them tell you HOW. View

Choosing the Best Device Sample Size for Verification and Validation - Webinar CD/Transcript

When performing process validations the question frequently asked is “How many do I need?” The answer is — it depends. There are several factors that must be considered when determining the appropriate sample size, including risks assessment, production costs, inspection costs, measuring, and testing. View

Spreadsheet Validation 2017 - Webinar CD/Transcript

What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View