Complete portfolio for a multinational

Situation

A multinational orthopedic company wanted to add a specific plate size to its product portfolio. Although the project had a low priority at its US-based headquarters, the additional size was critical for a European market. The company needed the new plate size to secure a local tender and maintain an important customer relationship. The company needed a partner that could move the project forward efficiently without placing additional pressure on its internal teams. It also needed support with regulatory documentation, manufacturing, quality management, and product delivery.

Capabilities

The ideal partner needed to be capable of acting as Legal Manufacturer. In addition, the partner needed to identify and extract the necessary documentation from the multinational’s document management system and update the design and associated documentation. After obtaining CE marking, the partner also needed to have the processes in place to manage product delivery, all while minimizing the resource burden on the client.

Solution

BAAT first familiarized itself with the multinational’s documentation system to identify and extract the relevant data for the plate. The documentation was then updated to align with BAAT’s Quality Management System and support CE marking. In addition, BAAT integrated the manufacturing, inspection, and delivery of the additional plate size into the existing production route. BAAT also managed inspection records, ensured traceability and process monitoring, and carried out the necessary post-market activities.

Result

The new orthopedic plate size enabled the company to secure the targeted tender and maintain its customer relationship in the European market. The product also generated additional sales in other markets after its introduction. As sales volumes increased over the following years, the company decided that bringing production in-house would provide greater benefits. BAAT supported the transition and helped the client move the product and associated processes to its internal operations. This project demonstrates how BAAT Medical can support medical device companies with CE marking, regulatory compliance, manufacturing, quality management, and market introduction while providing a flexible solution that reduces the client’s internal workload.