God bless Michael Seres. He was diagnosed with Crohn’s disease, an incurable bowel condition, at age 12. His first surgery at 14, he's 25 further surgeries stronger, having weathered intestinal failure and two bouts of cancer. He's now awaiting a ste...
Eyal Lerner, Ph.D., B.Pharm, ICQE
Pharmaceutical Quality Consultant firstname.lastname@example.org
I was not completely aware to Medicare & Medicaid Services (CMS) agency. It regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments and approve Laboratory Developed...
Hello All: In ISO 14971 Medical Devices--Application of Risk Management to Medical Devices clause 4.3 is "Identification of Hazards." It requires the manufacturer to compile documentation of known and foreseeable hazards associated with the medical d...
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...
As originally asked by
"Hip, hip, hooray! There's a new CPT code! I'm going to get paid!" you gleefully exclaim. "No you're not," health economist Nic Anderson said in this exceptionally valuable $350 consultation. I'm sharing approved, redacted portions of our call (yours...
As originally asked by Olufemi Adeoye. Can someone provide me with estimates on how much ISO 13485 registrar (CMDCAS for Canada) and EU notified bodies charge for certification as well as how long it takes; considering 1) Specification developer/Auth...
President at Ombu Enterprises, LLC
Acceptance sampling is a technique often used in verification of product. The sampling methods depend on either variables or attributes. Most device companies used published documents such as Z1.4, c=0, or Z1.9. There are other methods, although not ...
Goodmorning all, I have a question about the use of the IVD symbol on in vitro diagnostic products in USA. The IVD symbol as defined in ISO 15223 standard should be used to indicate "a medical device that is intended to be used as an in vitro diagnos...
Regulatory Affairs & Quality System
I'm based in India and would like to understand the overall regulatory workflow for medical device product development. What are the documents I need to create for entry into the US market? I've started on our 510(k). Do I need to have GTIN and GUDID...