![]() ![]() We specialize in catheter designs and process development (manufacturing), low volume prototype production, additive manufacturing/3D prototype development, laser weld (spot welds) and laser cutting processes, balloon catheter mold forming, test systems automation using LabView & C+ programs and equipment validation – GAMP5 (Ovens – Thermal Mapping, Drop Tester, Vibration Tester, Mechanical Testers). We are ISO-13485 & 21 CFR Part 11 Compliant. 95660 | Phone: 916.993.3799 | Email: Inc., a privately owned consulting company with over 25years of experience serving the biotech and medical device industry. PIL&M Inc., 3437 Myrtle Avenue #355- north highlands, ca. ![]() Revalidate as required if there are any changes to the computer systems or softwareįor further assistance regarding how to validate your new or existing equipment computer software/systems or commissioning contact us.Validated computer systems must be retained in a revision-controlled data archive application. ![]()
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