Contract Manufacturing for Medical Devices, Surgical Instruments, Orthopedic Implants, Catheter Systems
From first prototype to validated production, under one ISO 13485 quality system.
18M
Components shipped a year
99.7%
Lot acceptance rate
140+
Active OEM programs
Built to Spec. Documented to the Lot.
Our Quality SystemEngineering From Day One.
Our engineers review your design for manufacturability before it freezes, when a tolerance change costs an email instead of a revalidation.
Learn moreValidated, Not Just Inspected.
Every process runs under IQ, OQ, and PQ protocols, so quality is built into the process rather than sorted out at the end of it.
Learn moreScale Without Requalifying.
Prototype, pilot, and production run on the same equipment and procedures, so moving to volume does not restart your validation.
Learn moreFrom prototype to production
Manufacturing That Meets Your Regulatory Needs.
Most device teams come to us with a working prototype and a submission date. We build the manufacturing process that gets you from one to the other, with a design transfer package your auditors will recognise.
Design Transfer.
Process documentation built in
Supply Continuity.
Dual-sourced critical materials
Why Lindqvist.
- One quality system, start to finish
- Engineers who answer the phone
- Audit-ready records on every lot
What We Offer.
Six capabilities under one quality system
Machining, molding, assembly, marking, packaging, and engineering in one building in Plymouth, Minnesota. Your device does not cross a state line until it ships to you.
Starting a new program?
Bring Us In Before the Design Freezes. It Costs Less for Everyone.
A tolerance that adds a secondary operation or a material that needs a new supplier is easy to change on paper and expensive to change after verification testing.
How our NPI process worksGet a free design for manufacturability review on your next device.
- Written findings within five business days
- Cost drivers ranked by impact
- No obligation to build with us
Talk to a Program Manager(763) 555-0148
Engineering support
Engineers Assigned to Your Program, Not a Ticket Queue
Every program gets a named manufacturing engineer and a named quality engineer from the first DFM review through production. They know your device, your drawings, and your history, so a question gets answered by someone who already has context.
Meet the Team
Quality system
A Quality System That Is Ready for Your Auditors
ISO 13485:2016 certified and FDA registered, with electronic device history records, full material traceability, and supplier controls your auditors can walk through without a week of preparation.
Our Quality SystemWhat Device Teams Say.
4.9 / 5.0 Average customer scorecard rating, 2025
They caught a tolerance stack on our instrument that would have added a grinding operation to every part. That one DFM comment paid for the whole program.
Our notified body audit included a supplier walkthrough at Lindqvist. It took half a day and closed with zero findings. That is not normal and we know it.
We went from 200 pilot units to 40,000 a month without requalifying a single process. Same people, same equipment, same answers.
Insights for Device Teams.
Practical notes on design transfer, validation, and supply