Question
I know it's risky but if we play nice this could be a productive conversation. With one Presidental debate behind us, which candidate would be better for the medical devices industry? Or will either candidate be equally good (or bad) for industry? Th...
Earlier today I received the following question via LinkedIn: For verification and validation test records, are signatures needed?The person that asked the question thought the answer should be “Yes,” but is it required?This person read through the F...
Chirag Khurana wrote: Hello All, I am starting a WhatsApp group to discuss business opportunities in India for Medical Device Manufacturers. The group will be dedicated to foreign manufacturers, who want to enter the Indian market and are interested ...
There are, in distillation, three ways to go in the medical device industry. Many medical device companies work to treat unmet medical needs. That is the holy grail for wealth, job, and life satisfaction. It's a very tough way to go, requiring the mo...
Can anyone recommend a good NB in the UK? Both SGS and Intertek are refusing to take on any new work. We have been with LRQA for 18 months but we are getting nowhere with them BSI and UL are promising certification in a few months, but they all do th...
Hello , I am looking for HIPAA safe harbor requirements guidance . How can we implement process for compliance in an organization? What are the compliance requirements? What documentation needed for audit? Thankssource: https://www.linkedin.com/group...
The FDA actually reduced their fees this year, effective October 1, but the FDA offers fee reductions for small businesses too. Most of my clients qualify, but very few of these small businesses take advantage of the FDA fee reduction. Small business...
Hello, I'm wondering if there's a centralized publicly available list/ database of medical devices that have received the CE mark in Europe?Thanks for helping!Fiona
I am an engineer working with a regulatory affairs consultant. The person questioned my use of o-rings and whether they can be trusted to maintain a seal to keep out contaminants (in air, at low pressures). For me, its like asking whether I'm sure gr...
We introduced a new feature at our last 10x Medical Device Conference where we gave 20 guests three minutes each to introduce themselves. For today's discussion, I invite you to leave a comment to introduce yourself (virtually) to the Medical Devices...
