Wellspring’s team has extensive experience working within highly regulated, high-tech sectors such as Medical Devices, Lifesciences and Pharmaceuticals. Our engineers and specialists have worked with some of the leading Multinationals on projects such as Process & Product Development, MDR & Supply Planning, Manufacturing, Commissioning & Qualification of Biotech lines.  

We have the skills and proven experience to deliver valuable contributions on a contract or project basis, integrating quickly and adding immediate value to clients.

Example Projects Completed:

• Supply Plan management in support of extensive project to ensure 4000+ of clients products were reconfigured to achieve MDR compliance.
• On-site Commissioning & Qualification of equipment for new Biotech facility.
• On-site manufacturing process development for a new high-tech medical device in development with a leading pharmaceutical company.

For multinational clients, our services and strengths include:

• Six Sigma problem solving and process improvement delivered by Black Belt certified engineers
• Lean manufacturing implementation and optimisation
• Comprehensive process and product development support
• Validation of processes, products and software
• Commissioning & Qualification support
• Quality systems management including CAPA and NCEs
• FMEA for product and process risk assessment
• Project management for complex or high-value programmes
• Pre-audit support and regulatory readiness
• Product line transfers and scale-up support
• Coaching, mentoring and training for internal teams to strengthen in-house capabilities