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Certification Scope
When considering expanding operations to include activities outside the previously certified scope, what is the most appropriate sequence? Should we create procedures and practices that are inconsistent with the certified scope or update the scope first, although in this situation we wouldn't yet have any procedures to support that wider scope and certainly no evidence to show they were being followed (yet).
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The risks of losing the ISO 13485 Accreditation
What risk would my hospital be at if our SSD lost its ISO 13485 accreditation?
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Quick question on constructing the technical documentation
Thank you for the webinar and for taking the time to respond to my question. However, I wanted to follow up regarding your answer to my question: “Does a PMS Plan need to be prepared for the Technical File? Or can there be one, for example, for all Class IIb medical devices from a manufacturer?”
You mentioned that the PMS Plan has to be device-specific, but I am looking for some additional clarification. Could you please support this with a reference to any article from the MDR or a statement from the MDCG Guidance documents? My understanding is that the MDR indicates the PMS system is based on a PMS Plan, and it would be helpful to see the exact regulatory backing for your response.
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ISO 13485 - Quality agreement for subcontractor
I would appreciate your advice on the best way to complete quality agreement for subcontractor. -
ISO 13485 Compliance for Medical Device Stamping Process
I am currently working in medical device manufacturing and would like to better understand how stamping processes can be aligned with ISO 13485 requirements. Specifically, I am looking for guidance on:- Process validation requirements for stamping operations
- Documentation needed (SOPs, work instructions, records)
- Traceability and quality control measures
- Risk management considerations during stamping
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Temperature mapping of storage areas ISO13485
Hi all, We had an audit last month and one of the non-conformities was as follows: Infrastructure qualification A temperature mapping exercise is not available in the Company therefore it is not possible to evaluate the hottest and coldest points representative of the worst conditions for placing the Data Logger. Temperature is controlled and monitored in all our areas, however, there was no temperature mapping qualification performed. Temperature mapping is required for e.g. storage of pharmaceutical products (GLP/GMP/GDP), however, I cannot find evidence this is a requirement for storage of medical devices. I would like to know if this is mandatory. Thanks in advance! -
Classification of medical device according to MDR
Hello
Kindly ask for your advice in appropriate classification of medical device which is gel called to provide temporary protection to the surface of a typical surgical implant from the attachment of pathogens to the implant surface and the formation of a biofilm. Implant need to be coated with this gel before implantation. It has no drugs, no nanomaterials, manufactured without manufactured utilising tissues or cells of human or animal origin.
Thank you for your thought in advance -
Complex Therapeutic System - MD with ancillary medicinal substance + systemic drug
Hello, I am quite new to this area and I appreciate your opinion on the following issue.
My company is developing an implantable medical device that incorporates an ancillary medicinal substance (drug A), in which the drug action is secondary.
Adittionaly to the device, a second drug (drug B) will be administered systemically, reason why we are considering the medical device plus the drug B as a Therapeutic System.
The drug A was approved for clinical trials (for other medical condition) but is not in the market (the clinical trials ended because it showed no efficacy). The drug B is market-approved (oral formulation) but we need a systemic formulation that is not yet developed (we are planning a partnership with a pharmaceutical company responsible for this development).
My questions are:
Can we do a combined trial with the MD and the 2 drugs, once we need to validate the complete therapeutic system?
Can the drug A be directly approved for our clinical trial, once it was approved before for other clinical trials (by FDA)?
Thank you.
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Audit Question Stage 1 with FDA compliance
I recently had a client going through Stage 1 and the registration auditor commented on their procedures containing a reference to the CFR 820 as it pertains to their organization as a Distributor and a Servicer. They also were told they need to take an exclusion to Medical Device Reporting, it is not a requirement for a third party servicer, however it is required they have a documented process to record any adverse reporting. The auditor suggested this leaves them open for a more in depth "Audit". However - they distribute, install, service and repair the medical device. FDA would most likely audit this procedure if they were to come to their facility. Has anyone ever had an auditor from the registrar comment on this? -
ISO 13485 for supplier of microelectronic components
Hi,
We do supply packaged ASIC (application specific IC) to customer that manufacture medical devices. Our ASICs are not considered medical devices, and we have received ISO 13485 certification. Does this mean that we should also fulfill the requirements of ISO 14971? If yes, how can we evalaute the benefit of our components?
Regarding ISO 13485 clause 4.2.3, is it correct to consider this not applicable since we do not manufacture medical device, and we do not have medical device files?
Thank you.