Certifcates

Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

Managing Risks

Managing Risks

All of life entails some about of risk. The most humans can really do is mitigate the destructive effects of these risks that we take on a daily basis., the same goes with medical devices.

The Significance of Design Controls

The Significance of Design Controls

In the 1980s, the Food & Drug Administration (FDA) studied the causes of voluntary recalls of medical devices. Between October 1983 and September 1989, they found that about forty-four percent of these recalls were due to design issues.

Paperwork: The Necessary Evil

Paperwork: The Necessary Evil

No one genuinely enjoys doing paperwork. At best, people may dislike paperwork less than other parts of their jobs. Yet the FDA requires a certain amount of paperwork to document processes and results for the medical devices under their jurisdiction

Product Failures and Root Cause Analysis

Product Failures and Root Cause Analysis

In one’s personal life, many people just shrug their shoulders, and go about their day; however if a multi-million dollar investment, or someone’s life, is on the line, engineers need to take steps to prevent it from happening again.

Making Quality Systems Work for You

Making Quality Systems Work for You

If your QMS does not have the proper elements, personnel are not appropriately trained, or your firm does not really value the advantages of your QMS, you will likely not reap the same reward.

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?

Incorporating GDP through Lean Six Sigma

Incorporating GDP through Lean Six Sigma

GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during audits. GDP, or Good Documentation Practices, are essential to maintaining an effective QMS. In a previous blog post, we touched on GDP, ALCOA+, and recommendations for successful GDP practices. In this post, we’re going to take a deeper dive into GDP, the governing regulations, and tips on consistently maintaining GDP.

How does FDA regulate Complementary and Alternative Medicine

How does FDA regulate Complementary and Alternative Medicine

Ayurveda, which is a traditional system of medicine, originated more than 3000 years ago. This field of medicine pays larger emphasis on building strength of mind and body to cope with different kinds of stressors and infections.[i] There are studies which suggest that ayurveda can reduce pain, manage with symptoms of type 2 diabetes, etc.

FDA Warning Letters Are Public Information

FDA Warning Letters Are Public Information

For a medical device organization, a Warning Letter from the FDA is the worst kind of publicity.  It is an open disclosure of how poorly your organization complied with specific regulatory requirements. 

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