Production of microfluidic consumables
Striving for excellence in point-of-care manufacturing
We are committed to delivering high-quality, reliable Point-of-Care (POC) products that meet the highest standards of safety and performance. Our manufacturing facility is ISO 13485:2016 certified, demonstrating our commitment to quality management and continuous improvement.
What is ISO 13485?
ISO 13485 is an international standard that sets out the requirements for a quality management system for medical devices. It is a comprehensive standard that covers all aspects of the manufacturing process, from design and development to production and distribution.
Why is ISO 13485 important?
ISO 13485 certification gives customers confidence that our products are manufactured to the highest standards of quality and safety. It also demonstrates our commitment to compliance with regulatory requirements.
How does the ISO 13485 relate to the FDA
The relationship between ISO 13485 and the FDA is complex. However, in general, ISO 13485 can be used as a foundation for meeting the FDA's requirements. This is because ISO 13485 is a comprehensive standard that covers many of the same requirements as the FDA's regulations.
Our commitment to quality
We are committed to continuous improvement and regularly review our manufacturing processes to ensure that they meet the latest standards. We also invest in training and development for our staff to ensure that they have the skills and knowledge to produce high-quality products.
Contact us
If you would like to learn more about our manufacturing capabilities or ISO 13485 certification, please contact us. We would be happy to discuss your requirements in more detail.
The benefits of working with us:
- ISO 13485:2016 certified manufacturing facility
- Experienced and qualified staff
- Commitment to quality and continuous improvement
- On-time delivery
- We are the trusted partner for Point-of-Care manufacturing.
Manufacturing: Precision Manufacturing: Bringing Your Vision to Life
At Hahn-Schickard, we don’t just produce – we craft excellence. Here’s how we turn blueprints into reality:
- Seamless Handover: Your design seamlessly transitions to our in-house manufacturing department. It’s where precision meets production.
- Volume Commitment: Whether it’s 100,000 or 200,000 parts, we’re committed to delivering the agreed-upon volumes. Quality remains our compass.
- Tailored Hygiene: Your needs drive our protocols. Safety and efficacy are non-negotiable, customized to match your unique requirements.
