Risk is a word used to mean many things. I infer you mean medical device risk of the type that could result in harm to the patient or user. This excludes risk such as supplier risk, regulatory risk, etc.
As a relabeler/repackager, your company is a manufacturer and therefore subject to QSR; see the definition in 820.3(o). However, these activities are probably not covered by design control in 820.30, which is the source of “risk analysis”. You should exclude 820.30 for your relabeler/repackager activities as allowed by 820.1(a)(1), “If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.”
As a company that manufacturers a finished device, then QSR probably applies; some devices are GMP-exempt. If it does apply, design controls may not apply; some devices are exempt from design control. However, if design control applies, then you will need “risk analysis” under 820.30(g). The common methodology uses ISO 14971:2007.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 29-Mar-2017 15:56
From: Lauren Combs Viker
Subject: Risk Management File
Hello Everyone,
We are a <g class="gr_ gr_26 gr-alert gr_spell gr_run_anim ContextualSpelling ins-del multiReplace" id="26" data-gr-id="26">relabeler</g>/repackager and I was wondering if we have to keep a risk file/plan for items we relabel/repackage. We do not have any product specifications (i.e. line drawings) from the OEM's, but I wanted to make sure we are in compliance. We do manufacture some items and we do have risk mitigation and risk management files in place, but I cannot locate any guidance for <g class="gr_ gr_251 gr-alert gr_spell gr_run_anim ContextualSpelling ins-del multiReplace" id="251" data-gr-id="251">relabelers</g>/repackagers. Thank you for all of your time!
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Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
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