All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
Medical Devices
The Role of Management in Product Quality
Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system. 21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1] The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
EMMA International Consulting Group, Inc. and Thema Announce Strategic Partnership
EMMA International has entered into a strategic partnership with Thema, an Italian based strategic-regulatory consulting company. The goal of this strategic partnership is to expand geographical offerings to companies operating in the life sciences regulated space.
EMMA International’s Body of Knowledge (BOK)
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EMMA International, A Global Life Sciences Consultancy, Appoints Dharmesh Patel as Vice President of QA & RA
Mr. Patel has over 25 years of experience in quality assurance and regulatory affairs, with the past 12 years spent at the FDA.
October Brings Heightened Awareness to the Impact of Breast Cancer
October is the month that is designated internationally to bring awareness to the impact of breast cancer. The best screening tool to find cancer remains the mammogram. A mammogram is a low-dose x-ray picture of the breast. As in any cancer, early detection is key.
What to Do When Regulations Do Not Work (for You)
Some of the most challenging situations I have had to confront during my career have involved achieving compliance with regulations.
Pattern Recognition as a Quality Superpower
There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.
Record Control for a Regulated World
In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
The Digitalization of Quality Management Systems
One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.
HIPAA and GDPR’s impact on Medical Devices
The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.
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?
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