Question
CDRH published a list of guidance documents it is considering in fiscal year 2017. These include: Final Guidance Topics • Postmarket Management of Cybersecurity in Medical Devices • Medical Device Accessories: Describing Accessories and Classificatio...
I am currently handling our design history files, but I don't have any working knowledge of this process. Historically, we have assigned specific employees to jobs/functions in the program plan (so, the Engineering Role was filled by Bob, Quality Rol...
When you update your procedures for ISO 13485:2016 compliance this year, will you also be updating your template for procedures?My current procedure template has the following sections:1. A header with document title, document control number, revisio...
We in America have a new president with a decidedly "America First" platform. Will it help American medtech? From the December 2016 LIMEDex Index: • Stricter oversight of public spending with an “America first” bias could significantly affect procure...
MEDDEV 2.7/1 rev 4 is completely re-written from rev 3. The fourth edition is 19 pages longer and it is now much harder to use the “literature only” route. The fourth revision includes stringent requirements for demonstrating equivalence between anot...
Obtaining market access in many countries through product registration is a daunting and mostly manual experience. I invite you to learn a better way on February 1 at our free http://medgroup.biz/mktaccess webinar. Today, registering products is subj...
As originally asked by Dan O'Leary President at Ombu Enterprises, LLC The General Safety and Performance Requirements do not mention any specific harmonized standards. However, there are QMS and RMS requirements in various parts of the EU-MDR. No dou...
Visit the website for AdvaMed, the Advanced Medical Technology Association which looks out for American interests, and you'll read: "The innovation ecosystem that supports medical technology is severely stressed. The U.S. has historically been the wo...
In 2016, the Medical Devices Group surpassed 340,000 members. We gave seven free webinars, hosted the fourth annual 10x Medical Device Conference, and many of us met in person, talked here, and made valuable business connections. Here are the most po...
Imagine if you spent the last 6 months and $40,000 testing your new device in order to submit a 510(k). The week before Christmas you submitted your 510(k) and this week you are returning to work in anticipation of receiving confirmation that your su...
