Welcome to Pilgrim Software
Do You Know Where Your Documents Are?
Mark Crawford
According to the FDA, six words not to utter on FDA inspection day are: “Now, where is that darn document?” (It’s nice the FDA has a sense of humor, at least on paper).
Kidding…
Chinese Market Gets Hotter for Medical Devices
Mark Crawford
Citigroup Global Markets recently surveyed nearly 400 Chinese hospitals (about two percent of the country’s total) from 29 provinces and cities about attitudes toward the medical equipment market, medical consumable market, hospital construction…
How to Reduce Premarket Review Times
By: Mark Crawford
Medical device manufacturers (MDMs) know all too well how the FDA 510(k) review process of premarket applications for devices can seem to take forever. Although it’s easy to blame the FDA, there…
FDA Proposes Guidelines for Improving Representation of Women in Clinical Studies
Mark Crawford
On December 19 the FDA released a new draft guidance recommending improvements to medical device manufacturers’ clinical study designs that do a better job of evaluating the effectiveness of their products for women….
SOPs: What You Need to Know
Mark Crawford
According to the FDA, the problem cited in 60 percent of all warning letters is SOP—standard operating procedures.
That’s actually a good thing because it is relatively straightforward (but not always easy) to fix…
Supply Chain Management Is a Big Target for the FDA
By: Mark Crawford
According to Alan Schwartz of mdi Consultants Inc., a former supervisor of field operations for the FDA, supply chain oversight is the FDA’s next big area of concern.
About a year ago the…
Med Tech Is Hot in Germany
Mark Crawford
There is no question that Germany is one of the most prosperous countries in the EU—especially when it comes to medical technology products. According to Germany Trade and Invest, Germany ranks third in…
Recent Posts
- Do You Know Where Your Documents Are?
- Chinese Market Gets Hotter for Medical Devices
- How to Reduce Premarket Review Times
- FDA Proposes Guidelines for Improving Representation of Women in Clinical Studies
- SOPs: What You Need to Know
- Supply Chain Management Is a Big Target for the FDA
- Med Tech Is Hot in Germany
- Pre-IDE Meetings Can Be Helpful in Understanding FDA Expectations
- Mobile Medical Applications Are a Challenge for the FDA
- Q&A with Bill McLain on Internal Audits
Pilgrim Software News
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