Regulatory Open Forum

Dear All,

Could anyone recommend a consultant who can help with the preparation of a validation test plan and report for a surgical device? Ideally, this should be someone who has experience in the OR.

Thank you in advance!

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Virginia Anastassova RAC
Manager Regulatory Affairs, Senior QA Specialist
Starfish Medical
Victoria BC
Canada
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Virginia, just to clarify, I think you are talking about DESIGN validation, not PROCESS validation?

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Julie Omohundro RAC
Durham NC
United States

Original Message:
Sent: 01-05-2016 19:28
From: Virginia Anastassova
Subject: Looking for consultant for surgical equipment validation

Dear All,

Could anyone recommend a consultant who can help with the preparation of a validation test plan and report for a surgical device? Ideally, this should be someone who has experience in the OR.

Thank you in advance!

------------------------------
Virginia Anastassova RAC
Manager Regulatory Affairs, Senior QA Specialist
Starfish Medical
Victoria BC
Canada
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Well, on further thought, I don't know. Perhaps "validation" is viewed differently by Health Canada versus FDA?

For FDA, design validation isn't testing (that's design verification), but a clinical trial (or a darn good simulation of use under conditions of use).  I would want someone experienced in the OR involved, but I would want them to establish user requirements (which is what you are validating, that it meets those requirements) and to provide some input into the protocol, but not to design the trial or write the report.  To design the trial, I think you would want someone experienced in designing device trials.  If this is for regulatory approval, then preferably someone experienced in designing trials to be submitted to the appropriate agency.  Experience designing surgical trials I think would be a plus, but actual experience in the OR I don't think is necessary to design the trial or write the report.

Process validation is validation of the manufacturing process, which does not require experience in the OR, but experience in manufacturing.

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Julie Omohundro RAC
Durham NC
United States

Original Message:
Sent: 01-06-2016 23:00
From: Julie Omohundro
Subject: Looking for consultant for surgical equipment validation

Virginia, just to clarify, I think you are talking about DESIGN validation, not PROCESS validation?

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Julie Omohundro RAC
Durham NC
United States

Thank you all for your suggestions! My client needs help with writing the protocol and the report for design validation for a 510(k) submission. They have people experienced in the OR but don't have any experience with validation and my company does not provide this service.  User requirements are already defined. I hope that provides some clarification.

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Virginia Anastassova RAC
Manager Regulatory Affairs, Senior QA Specialist
Starfish Medical
Victoria BC
Canada

Original Message:
Sent: 01-06-2016 23:16
From: Julie Omohundro
Subject: Looking for consultant for surgical equipment validation

Well, on further thought, I don't know. Perhaps "validation" is viewed differently by Health Canada versus FDA?

For FDA, design validation isn't testing (that's design verification), but a clinical trial (or a darn good simulation of use under conditions of use).  I would want someone experienced in the OR involved, but I would want them to establish user requirements (which is what you are validating, that it meets those requirements) and to provide some input into the protocol, but not to design the trial or write the report.  To design the trial, I think you would want someone experienced in designing device trials.  If this is for regulatory approval, then preferably someone experienced in designing trials to be submitted to the appropriate agency.  Experience designing surgical trials I think would be a plus, but actual experience in the OR I don't think is necessary to design the trial or write the report.

Process validation is validation of the manufacturing process, which does not require experience in the OR, but experience in manufacturing.

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Julie Omohundro RAC
Durham NC
United States

Hmmm.  I would argue that if the device is substantially equivalent to the predicate (i.e., can be cleared via the 510(k) process), the design has already been validated, through clinical use of the predicate device.  If that isn't the case, then the device may not be suitable for a 510(k).

Also, when you say "for a 510(k) submission," I'm wondering if you mean that the client is planning to include the design validation report in the submission itself?  That is not something that is usually included in a 510(k) submission.  But maybe you just mean hat they need the report for a device for which they are preparing a 510(k) submission?

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Julie Omohundro RAC
Durham NC
United States

Original Message:
Sent: 01-07-2016 11:40
From: Virginia Anastassova
Subject: Looking for consultant for surgical equipment validation

Thank you all for your suggestions! My client needs help with writing the protocol and the report for design validation for a 510(k) submission. They have people experienced in the OR but don't have any experience with validation and my company does not provide this service.  User requirements are already defined. I hope that provides some clarification.

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Virginia Anastassova RAC
Manager Regulatory Affairs, Senior QA Specialist
Starfish Medical
Victoria BC
Canada

Most people get confused between verification and validation. Typically design verification is always required using a traceability matrix.  The input for the traceability matrix comes from the design input and risk management.  You may have many verification protocols and reports for a device.  I have generated many design verifications and be more than happy to help.

Thanks,

Armin

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Armin Beck
CEO
SunTrixConsulting LLC
El Dorado Hills, CA
1-925-212-7683
armingbeck@aol.com

Original Message:
Sent: 01-08-2016 03:44
From: Julie Omohundro
Subject: Looking for consultant for surgical equipment validation

Hmmm.  I would argue that if the device is substantially equivalent to the predicate (i.e., can be cleared via the 510(k) process), the design has already been validated, through clinical use of the predicate device.  If that isn't the case, then the device may not be suitable for a 510(k).

Also, when you say "for a 510(k) submission," I'm wondering if you mean that the client is planning to include the design validation report in the submission itself?  That is not something that is usually included in a 510(k) submission.  But maybe you just mean hat they need the report for a device for which they are preparing a 510(k) submission?

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Julie Omohundro RAC
Durham NC
United States