Medical Devices Overview

For more than a decade, PV has supported Fortune 500 companies, foreign subsidiaries and smaller medical device companies for their medical device validation needs. Whether it is a small or large project, PV helps with defining equipment requirements, installation qualifications, and final assembly processes.

PV serves the following areas:
Pharma, Biotech, CDMO, CMO, Animal Health, IVD manufacturing, Key industry suppliers

Types of Services:
Macro validation planning and reports I Risk analysis development I Project management (including expense, project, and milestone management) I Process Validation Expertise I Quality System Development I FDA Remediation

Learn more about Medical Devices

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Alex Wegner

Med Devices Services Manager - Alex has over eight years of experience in medical devices and manages the validation and PPAP teams. He has vast experience with developing and executing equipment qualification, test method validation, and process validation documents to ensure they meet the quality system and regulatory requirements. He has led multiple large validation projects that have ranged from new manufacturing lines to transferring product lines from one site to another.

Schedule with Alex Wegner

Alex Wegner

Med Devices Services Manager - Alex has over eight years of experience in medical devices and manages the validation and PPAP teams. He has vast experience with developing and executing equipment qualification, test method validation, and process validation documents to ensure they meet the quality system and regulatory requirements. He has led multiple large validation projects that have ranged from new manufacturing lines to transferring product lines from one site to another.

Schedule with Alex Wegner