Anna Lisa Somera
Start Up Mentor and Grant Consultant
Someone told me that it's possible for a med device company to use their contract manufacturer's ENTIRE quality system as their own. He said since design and development is outsourced, his company could just use all of the manufacturer's procedures a...
QA Engineer / Software Developer
Hi,I was hoping to get some help and alternative opinions on a classification query I have. We sell instrument trays used to hold the instruments during reprocessing and sterilisation. I'm not sure whether they should be classified as a medical devic...
Directeur Assurance Qualité / Responsable Affaires Réglementaires Sécurité Produits chez SEPPIM SAS
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...
I met a molecular biologist last week at BRINK 2015 (which was excellent). He's turned his attention to oncology. I paraphrase, but he basically asked if we knew any billionaires with cancer. He wasn't being elitist. Or looking to deny service to any...
Dr Fatima Zaid Abu Zanat
Regional Regulatory Affairs & Scientific Office Manager at Mundipharma International Limited
Hi Colleagues!Does anyone have the medical device regulations/ guidelines for West Africa (Ivory Coast, Senegal, Mali, Cameroon, and Gabon)?How long does it approximately take to complete the registration process especially for Class IIb and III medi...
Hello, I wonder if someone could advise under which category of Medical Devices an injectable insulin pen would fall? Thanks
Over the years, a number of trucking, shipping, and delivery companies have asked me how they can get a foot in the door of medical device companies. And this week a group member asked, "What do the top medical device companies do to warehouse their ...
M.D., Ph.D. Pediatric Cardiologist, Professor of Pediatrics
Assistan Professor (dr hab.) w Uniwersytet im. Adama Mickiewicza w Poznaniu
As far as I know it is not obligatory to have one to get 510(k) cleared in FDA. There are no medical devices on OSHA list. However most of the people say that it is necessary in practice, because hospitals and other institutions do not want to use d...
Executive Assistant at Social Entrepreneurial Enterprises INC
I have a question regarding used/refurbished devices, Does anyone know which countries are allow to sell them? and the regulations? source: https://www.linkedin.com/groups/78665/78665-6017094814523285506