Regulatory Affairs & Quality System
Can you explain what Article 22: System and procedure packs of EU MDR means?What, exactly, do we do to comply with this article?
Minoti Patel, RAC (US)
Manager, Regulatory Affairs at Thermo Fisher Scientific
Thoughts - A device such as ultrasound device, whose life span is 5 years. In its 6th year device does not work properly. The customer calls the manufacturer. The manufacturer offers to repair the device even though the device is outside its lifespan...
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If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% ...
As originally asked by Graham Ball. The company I am working with supply a part which is built into monitoring and control devices used in the medical field. None of the devices are implanted in any way. Our customer supplies the final product to the...
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The most common nonconformity identified by reviewers of a CE Marking submission is an inadequate or missing clinical evaluation report (CER). Preparing a CER is time consuming, but if you have a good protocol and procedure the process does not need ...
regulatory engineer presso Lima Corporate
I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking. Are there any conflicting int...
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...
"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...
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 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...