Question
What happens after a customer calls in with a question, complaint, or need? If you handle the call, hang up, and move on to the next caller, you're missing a big opportunity, says Sarah Wright, Director of Global Customer Support, Healthcare Informat...
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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...
What (exactly) does it take to orchestrate and command a successful launch of an entirely new medical device? Such as a device that can be categorized as the "next revolution" in a medical specialty and/or represents a disruptive technology. I am par...
Justyna-Wanda Niewiadomski, MBA
Director Group R&D Quality & Clinical Affairs Management bei Sonova Gruppe bei Sonova Gruppe
May 2016
To get an CE Mark for a device which needs to go to a clinical study and do not have any results to proof the safety and performance requirements. Is there a similar process/procedure in Europe like in Us for the IDE (Investigational Device Exemption...
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...
Can someone share what and how he is doing packaging and labeling validation for a non sterile product ? Quantities? Parameters ? Forms ? How many batches ? source: https://www.linkedin.com/groups/2070960/2070960-6232416918385487874
Like many of you, I have been slogging through the Practical Guide to ISO 13485:2016 since it came out end of September. To be honest I found it anything but practical. The guidance is a behemoth at 214 pages, contains circular references with vague ...
I'm very interested in your take on this. Mahesh Mulumudi, MD, is Division Chief of Medicine for Providence Regional Medical Center. He probably has as much influence on hospital buying decisions as any clinician there. Which made his comme...
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...
