Question
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...
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...
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...
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...
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...
Hi all, I am looking for a simple protocol to file a 510k exempt device to FDA, since FDA provides so much detailed information of 510k and PMA on the website. I will be grateful if someone could share some simple tips of what I should do for the 510...
According to Article 13 of the new medical device Regulation entitled “Person responsible for regulatory compliance” , “manufacturers must have available within their organization at least one person responsible for regulatory compliance who possess...
Frequently I am asked if minor device modifications, such as a color change, requires a new 510k submission. In general the answer is typically yes, and this surprises most manufacturers. In order to help make this decision, the FDA released a new dr...
As per process validation definition in ISO-13485 and FDA CFR 21 Part 820 I have a concern where help from groups members is really appreciated,Recently I read a procedure that states that, since regular lots size are too big, sampling can be conduct...
So, ISO 14971:2007 is officially going into a revision as deliberated in the ISO TC 210 Delft meeting today. Now the work begins!!source: https://www.linkedin.com/groups/2070960/2070960-6204883472100651009
