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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.
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Multiple scope in one certification
Our company is certified for meeting ISO 13485 requirements for the scope of design, development, manuafcture and sales of product for brand A. Our Parent company has requested to get certified for their brand (i.e Brand B) with the scope of manufacture aand sales of products. Would this be treated as a spearate certification and would require both stages of audits? or can be integrated with existing one as an extension of scope
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Repackaging of a medical device
The company, which is a distributor of medical devices but not an authorised representative, plans to purchase medical devices in various EU countries and supply them repackaged to other EU countries. The repackaging operations would be as follows: replace the outer packaging (box), stick a new label on the container and adding instructions for use. The package, sticker and instructions would be in the language of the country to which the medical device is to be supplied. The integrity of the inner container would not be compromised. Do I understand correctly that according to the requirements Article 16 of MDR, such a distributor would have to apply to a Notified Body to have its quality management system assessed by NB?
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Contract Review Scope
What is the scope of contract review? What triggers a contract review? We are currently reviewing all POs regardless whether they are for existing parts or for new parts. It seems like overkill and basically contract review has become a production planning process rather than a contract review process. The focus is purely on do we have the material and capacity to meet the customers due date. By doing this this, we miss a thorough review of new part requirements because we are overloaded with existing part contract reviews that need to be quickly.
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MDR Deadline
We are a Class I and Ir dental hand instrument Manufacturer, Repackage and relabeled. We have never been certified to EU MDD or EUMDR. When is our deadline to get a Notifying body to accept us and to complete our MDR certification?
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Identifying gaps between ISO 13485 and ISO 9001
We are currently ISO 13485 certified. We would like to become ISO 9001 certified. Do you have anything that will help me identify the gaps that we need to fill?