Health Buzz: The 10 Best States for Health Care

  If you want to get the best health care, you might be better off living in one of these states, according to a new ranking. Hawaii, Iowa and Minnesota topped WalletHub’s new ranking of the best states for health care. The ranking took into account 35 metrics in the categories of cost, accessibility and health […]

The Ultimate Guide To Design Controls For Medical Device Startups

    What’s this guide about anyway? Back in 1998, I started my career as a medical device product development engineer. At that time the FDA Design Controls regulations were still fairly new — not only to me — but the industry in general. In those days, we all struggled to understand how and what […]

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem

Development of technical training in the life sciences

Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers.

Do human factors matter in medical devices?

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents

Quality by Design using Design of Experiments 2017

The ICH has offered further guidance and policies for explaining the ways by which the QbD approach should be integrated into the pharmaceutical Quality System

Seminar Calendar of Upcoming Courses – June to July – 2017

seminars are a wonderful opportunity for professionals in the regulatory compliance

Understanding the FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials

The establishment of the initial safety of a drug is the primary reason for which early clinical trials are conducted. Phase I of drug development consists of: o  Research and drug discovery o  Preclinical development, of which initial IND, or first in humans (also called first in man), is part o  Clinical development, which consists of Phase I, […]

Tips and Suggestions on interacting with FDA Officials and Premarket Approval (PMA)

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance. What makes preparing premarket submissions that win regulatory approval […]

Article on “Statistical Sampling Plans for Medical Devices”

One of the important aspects of design control of medical devices is statistical sampling plans for medical devices. To gain an understanding of the idea of statistical sampling plans for medical devices, one needs to understand the process of medical device design controls. Statistical sampling plans for medical devices needs to be seen in this […]