Implantable Devices

Implantable device manufacturers face many challenges in the current landscape. As Current Good Manufacturing Practices (CGMP) are continually refined and evolve each change offers new benefits but also presents unique challenges. Additionally, operator subjectivity and the possibility for human error have continually presented problems for manufacturers.

Throughout our history VEI has developed solution based products to meet the industry’s current needs. Product mix, quality defects, software discrepancies, and mislabeling are a few of the problems VEI’s product lineup addresses. Our solutions employ a variety of technology to successfully mitigate risk while further reducing cost. Common medical device sectors include orthopedics, ortho recon, maxillofacial, spine, & dental.

Cardiovascular Implants

Comparable to much of the medical manufacturing community the cardiovascular industry faces increasing regulation and compliance measures both locally and abroad. Furthermore, in an industry where one mistake is one too many the demands placed on manufacturers continue to grow. Challenges are in part due to increasing pressure to further miniaturize devices, material reduction, and implementation of improved manufacturing methods. With these challenges quality checks can become increasingly difficult and as such the absence of all errors is simply not realistic. VEI offers both custom and off the shelf packages designed to meet these needs.

Biologics

The biologics industry faces complex manufacturing processes in part due to fermentation, aseptic processing, storage & testing requirements. Hence, it’s understood that biologics are more expensive than simple chemically fabricated drugs. Additionally, due to biologics intended use often dictating FDA classification drugs can fall into categories of both a medical device and biologics. This results in extensive quality control measures focusing heavily on the drug’s assays and the like. Nevertheless, few systems adequately protect against drug, label, or other product mix situations. At VEI we provide solutions to meet this need and mitigate risk.

Clinical Trials

VEI offers several solutions which can assist with FDA requirements concerning the control of materials, labeling, reporting, and process controls.

Pharma

Offering a variety of quality based solutions for data logging, process monitoring, and including printer label verification, pill integrity, quantity, color, reporting & ERP integration.