Question
Aurélie HOUEL
Directeur Assurance Qualité / Responsable Affaires Réglementaires Sécurité Produits chez SEPPIM SAS
September 2015
Hi,I hope to have some help on sterilization process with an autoclave which has no drying cycle.We use this autoclave to improve the state of cleanliness of our material used during the manufacturing process. We want to change this process, but I ne...
We know several medium and large med device companies that still claim, “we sell boxes.” They may not say exactly that to customers, but inside the company they use those words, and usually with a mixture of pride, arrogance, and I think fear. Unfort...
ISO9001:2015 + Context of the organization + relevant interested parties needs and expectations (Like the FDA / MDD / etc) can very well be equated to ISO13485. So why at all we need the ISO13485 in a new release that will be still old ... ?source: h...
ISO, the International Standards Organization, tells us risk-based changes to the ISO 13485 standard are "to be published by the end of 2015." The new 13485 will build upon principles laid out in ISO 14971, the current risk management standard for me...
Roberta Goode
President at Goode Compliance International: Experts in Process Validation and FDA Compliance
September 2015
Why do customer complaints nonconformances continue to escalate to WLs and 483s at an alarming rate? Has something changed in the way companies are (mis)interpreting the regs, or is it more subtle? I'm curious to know what the group members think.sou...
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
September 2015
In this paper, I outline in detail the structural biases against anything new in the medical technology realm, including novel software. I wholeheartedly support FDA regulation of risky technology, but the law places disproportionately large regulato...
I'm reaching out to others who have worked with and/or supplied to the Medical Incubator community. What is the best process for getting integrated as a supplier within the community? How does one get on an incubator AVL list or an incubator supplier...
*This is not professional advice.* In fact, it's borderline irresponsible, but here goes. So I was talking to this guy who found me from the group. To protect his anonymity, I'll be vague about his selling proposition. He told me he's building an app...
As originally asked by
I am particularly interested to learn whether anyone in this group has tackled the challenge of (or is aware of) any new point of care devices that are able to diagnose tuberculosis (in particular, multi-drug-resistant tb) in a way that is more effic...
