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Ian Miles Reply-To: Ian Miles To: achaveste@traceseis.com Subject: RE: Question about medical device software and regulatory compliance Date: Mon, 22 Jun 2026 14:27:59 -0400 MIME-Version: 1.0 Content-Type: multipart/alternative; boundary="=-BDHhclrLOfsUkW/6CTvd8g==" X-Spam-Status: No, score=0.2 X-Spam-Score: 2 X-Spam-Bar: / X-Spam-Flag: NO --=-BDHhclrLOfsUkW/6CTvd8g== Content-Type: text/plain; charset=utf-8 Content-Id: Content-Transfer-Encoding: base64 DQoNCkhpIEFsdmFybywNCg0KRm9sbG93aW5nIHVwIG9uIG15IHByZXZpb3VzIGVtYWlsLCBkbyB5 b3UgY3VycmVudGx5IHdvcmsgb24gdGhlIHJlZ3VsYXRvcnkgZG9jdW1lbnRhdGlvbiBvciBzaW11 bGF0aW9uIHNpZGUgb2YgdGhpbmdzIGZvciB5b3VyIG1lZGljYWwgc29mdHdhcmU/DQoNClJlYXNv biBJIGFzayBpcyBNYXRoV29ya3MgcmVjZW50bHkgd29ya2VkIHdpdGggTWVkdmlzbyB0byBjdXQg RkRBIHJlZ3VsYXRvcnkgc3VibWlzc2lvbiBkb2N1bWVudGF0aW9uIHdvcmsgaW4gaGFsZiB3aGls ZSB0cmlwbGluZyBkZXZlbG9wbWVudCBzcGVlZHMuIDxodHRwczovL2FwcC5nby5tYXRod29ya3Mu Y29tL2UvZXI/c192MT02NjczNyZlbHFlbT1NZWRpY2FsJTIwRGV2aWNlcyUyMDEmcmVjX2lkPWQy 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