Naman, welcome to the Safety Community. I hope you will find the Safety Community to be a tremendous resource to meet your goals. If you have the time, we would benefit from your knowledge and experience with Forum discussion(s).
Audits are a means of evaluating operations and other functions of an organization. ISO 19011:2011 Guidelines for Auditing Management Systems describes audits as a process used for gathering the evidence of verifiable documents and map their suitability, alignment and fulfilment with the company’s policies and procedures.An audit is an important tool that helps organizations to analyze opportunities, implement best practices, and assess all the important factors in a business, such as risks,…See More
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)…See More
Hi everyone!For full transparency ill tell you a little about myself and what I hope to accomplish. My name is Zuber and I'm an engineering student who founded a startup helping to build wearable…Continue
We have what we feel is not a unique situation and were wondering if anyone might of run across this challenge and know more about the requirements. We are building a small machine system that…Continue