Satisfy internal and government requirements with process validation for medical device manufacturing. Ensure your entire system and the EOL deliverable meets government requirements.
Data Validation Automation Tools
Ensure Product Quality Standards
Before introducing a new medical device into the market, manufacturers need to have a high degree of certainty that their processes have the proper controls to meet applicable standards and requirements.
The Lanco Integrated process for validation of medical device assembly systems meets the highest demands of the industry. Our engineers develop US FDA and ISO 13485 compliant processes. Process validation goes hand-in-hand with process control and you get industry leading guidance in both from Lanco Integrated. You’ll benefit from our long-term plan and strategy.
Maintain compliance with a complete GAMP® 5 validation process that includes:
- Design Qualification (DQ)
- Safety Qualification (SQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
Extensive Industry Experience
Partner with a Global Leader
From forming your initial validation team all the way to any necessary revalidation steps, we partner with you to assist in the creation of a comprehensive validation plan. Our automated systems reduce labor and ensure consistency in the execution of your plan. Rely on our decades of expertise with medical automation. Medical manufacturing plants around the world lean on us for compliance.
Automotive - Brake Module
Semi - Automatic Brake Module assembly on our Lanco HFL 2002 -S pallet transfer system.Explore Resource
Commercial Industrial - Sprinkler Assembly
Fully Automated System producing 4.5 Parts per minute with 100% quality Inspection.Explore Resource
Consumer Products Brochure
Lanco is acutely aware of the importance of time-to-market in the Consumer Products sector and the need to produce cosmetically perfect parts.Explore Resource
From concept and development to finished product and after-sales service, Lanco Integrated empowers global assembly.Explore Resource
Lanco Integrated specializes in creating modular powered and free and cam driven assembly systems designed for future expansion and changes based on customer needs.Explore Resource
Covid 19 - How an Automator partnered with customers to tackle Covid
Lanco Integrated 2020 Partnering with customers to tackle Covid on multiple fronts. From diagnostic test kits, sanitizer dispensers and Trigger pumps for disinfectants, Lanco's assembly systems have produced millions of components critical to the fight against Covid.Explore Resource
Delivering precision solutions for technical medical device and diagnostic requirements, Lanco stands with its customers.Explore Resource
OKU - German
The cam system is designed to last for decades with regular maintenance.Explore Resource
Pallet Transfer System
The versatility of the Lanco’s Transfer system makes it easy to adapt as production demands change and grow.Explore Resource
Pallet Transfer System MPS 120
Lanco Integrated's Mini Pallet Transfer System is a modular transfer platform for material handling, assembly manufacturing and test systems.Explore Resource
Pallet Transfer System HFL 2002-S
The HFL 2002-S Pallet Transfer System is a modular, non-synchronous transfer platform for material handling, assembly and test systems. It is suitable for creating lean manufacturing cells and building semi or fully automatic systems.Explore Resource
Empowering Global Assembly
Benefits of Our Validation Process
Document Validation Steps
The US FDA requires documentation of your process validation. Process validation reduces the labor involved in generating that documentation. This critical step is customized for your specific requirements.
Right now, our validation processes help companies comply with stringent rules from dozens of regulatory agencies around the world. Our validation process includes DQ, SQ, IQ, and OQ to meet the respective FDA and TÜV requirements.
Build a Partnership
With our Total Service Solution, the process validation system we build for you is the foundation for a lasting partnership invested in your success. Produce your medical device supported by highly credentialed automation engineers across the globe dedicated to ensuring you achieve the highest outputs within all applicable regulations.