Unique Device Identification (UDI)

The Challenge

A Fortune 500 medical device manufacturer needed to update existing product laser markings to comply with the Unique Device Identification (UDI) FDA Regulation per Code of Federal Regulations Title 21 Volume 8 Part 801 (21CFR801). This involved investigating the different materials that are laser marked and developing the settings for a marked barcode that is compliant with the UDI Regulation.… more


Robotic Welding Station

The Challenge

A Fortune 500 medical technologies firm wanted to reduce the manual input and cycle time when building battery cell clusters for their battery driven devices by installing a robotic welding station.  The engineering staff were knowledgeable in the equipment and intended process flow, but since this was a novel station, no one had previously qualified a complex automated station or the SCADA and PLC systems required for the process at this site.… more


Laser Welder Validation

The Challenge

A Fortune 500 medical device manufacturer wanted to add a new laser welder to their production facility to improve manufacturing throughput and reduce scrap rate. The engineering staff at the medical device company were familiar with the equipment and its intended use; however, this model of laser welder had not been previously used or validated at the company.… more


Medical Device Line Retrofit

The Challenge

A leading medical device manufacturer sought to add a new product to an existing production line. This required a retrofit of the previously validated line, requiring an assessment to determine if existing documentation met current regulatory standards. Additionally, new processes and simple fixtures were being added to the production line to accommodate the new product.… more


Coordinate Measuring Machine (CMM) – Validation

The Challenge

A Fortune 500 medical device manufacturer desired to introduce Coordinate Measuring Machine (CMM) capability to reduce inspection time when measuring complex component geometry during incoming inspection.  The engineering staff at the medical device company were familiar with the equipment and intended use. … more


Facility Renovation for New API

The Challenge

A leading manufacturer of over-the-counter store brand pharmaceutical products underwent a facility renovation for a new product line.  In order to safely manufacture and regulate the new active pharmaceutical ingredient (API), a reconfiguration of utilities including HVAC, dust collection, purified water, compressed air, and nitrogen was required.… more


Freeze Dryer Upgrades

The Challenge

A large mid-western pharmaceutical company planned to add feedback to the primary pins on its suite of eight freeze dryers already in use.  Significant constraints existed on the schedule because a facility shutdown was required to integrate feedback of the primary pins into the programming and multiple other projects were being implemented in parallel on the equipment. … more