Hello Abi, I forgot to mention a few things. First, this effort may also be somewhat of a retrospective design history file event. In so doing, remember that we are still nonetheless required to approach it with scientific objectivity. Therefore, be careful not to compromise the objectivity and scientific validity of the event by improperly consolidating or capturing documentation.
For example, it is generally understood that design verification shall precede design validation. Consequently, if one attempted to consolidate verification and validation together, it would generally undermine and compromise the integrity of the verification and validation campaign.
Remember also that the design inputs [the phase where applicable standards and various requirements (e.g., critical and non-critical) are to be identified and prescribed] needs to be done before proceeding to the design and verification/validation stages. Accordingly, don't make the mistake of waiting to identify those design targets (e.g., required conformity with certain standards; risk-ranking of the requirements, etc.) until the verification/validation stage or until the end. Otherwise, your scientific method and DHF will be compromised.
Also be sure not to overburden the contract manufacturer/designer with a blanket expectation for ISO 13485 conformity. Would it be nice if they complied with ISO 13485? Sure. Is that a requirement? Not necessarily. And from a purely legislative/regulatory perspective, not at all.
On the note of the contract manufacturer/designer, don't wait until the end to get the quality agreement in shape. I would instead view the quality agreement itself, if part of the DHF at all*, to be a design output that answers the manufacturing design inputs previously created. *But ultimately, it is generally best in my opinion not to mix up design and development controls with purchasing/supplier controls beyond what is needed, for example regarding a contract manufacturer, regarding identifying customer (you're the manufacturing customer) needs, manufacturing design inputs, manufacturing process design (even if such process is acquired off-the-shelf so to speak), manufacturing verification and/or validation, corresponding design transfer, etc.
In addition, when approaching risk management documentation, my work on the U.S. ISO 14971 standard working group and in risk management file remediation has taught me that it is best to strictly adhere to the terms of ISO 14971 rather than applying or inventing risk terms or concepts that don't match what is in ISO 14971. For example, the best and proper terms are ones like identification of hazards, sequences of events, hazardous situations, and harms, and doing so via "risk analysis".
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 14-Feb-2024 15:41
From: Beatrice NAJEM
Subject: Design Specifications (Inputs & Outputs)
Hi Abiola,
I am totally aligned with Keven & Richard.
The design and conception documentation are required under MDR. They were also required (in a lighter way by the MDD).
I had this case recently.
I recommand you to be back to manufacturing documentations with your physical manufacturer. In my opinion, part of them would already exist (like PFMEA, MQP, DMR, drawings and specifications, packaging transit). The physical manufacturer even if he is not the LM, should appy the ISO 13485 and keep records of production.
Others would be to consolidate: design verification and validation protocol and reports - with all applicable standards depending on the product (active, implant, etc.), hazard analysis, design hazard analysis, ...
Best way to check is to consolidate a check-list and evaluate gaps and risks. Once you consolidate the DHF, I would recommend to review the quality agreement and introduce critical requirements (at least the product technical specifications & R&r).
Hope this helps,
Béatrice
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Beatrice NAJEM
CEO & Founder of quarex consulting LLC
Belmont MA
United States
Original Message:
Sent: 13-Feb-2024 10:42
From: Abiola Bamigbade
Subject: Design Specifications (Inputs & Outputs)
I would appreciate information on which documents could be submitted to a notified body for Design Specifications (Inputs & Outputs) as part of the Technical File document review for a legacy device transitioning to the MDR.
The context to this is that the medical device has been successfully placed on the EU market under MDD for twenty-plus years as a virtual manufacturer (while that title was still acceptable). The Original Equipment Manufacturer (OEM) was responsible for the design and production. The OEM (now contract manufacturer) is still responsible for the manufacturing and design, but no design changes had taken place since the product launch and there is a remote chance of getting the original documents relating to pre-launch design activities at this stage.
Pragmatic suggestions of documents that can be raised (retrospectively) that would satisfy Design Specifications (Inputs & Outputs) will be highly appreciated.
Any ideas of how others have successfully managed this aspect of the technical file review while transitioning to MDR are welcome. Regards.
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Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.
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