Medical

Ensuring Uncompromised Production Integrity for Medical PCBs Post-Qualification

Choosing a PCB manufacturer for medical products is a critical, long-term commitment. Once your PCB design is finalized and the medical product receives FDA or notified body approval, any alterations in design, materials, or manufacturing processes can pose significant challenges. At GS, we are not only fully aware of these challenges but are also fully committed to ensuring that your PCB continues to be manufactured as approved, with no unauthorized changes from the manufacturer. Your trust in our process and dedication to maintaining production integrity is our top priority.

Typical Medical Applications Powered by Our PCBs

Junge Frau mit einem Cochlea Hörgerät.
Cochlear Implants
Two in-the-ear hearing aids in the palm of a hand.
Hearing Aids
X-ray of implanted pacemaker.
Implanted Pacemakers
Ultrasound examination of man with ultrasound sensor.
Ultrasound
Two e-pills with cameras for endoscopic examinations.
E-Pills
Catheter with camera image on computer monitor.
Catheters

Our Approach to Meeting Your Requirements

Comprehensive Technical Support

Design for Manufacturing:

We ensure your designs are optimized for manufacturability, enhancing efficiency and quality.

Quality Assurance

Critical Quality Parameters: 

We establish and agree upon key quality parameters to meet your standards and expectations.

Reliable Testing:
For implants and on customer request, our extensive testing protocols ensure the proper functioning of test equipment before and after PCB testing.

Consistency and Reliability

Consistent Processes:

We use the same processes and equipment for both prototype and series production, making requalification unnecessary.

Change Control:

No changes are implemented without prior customer approval, ensuring complete control and transparency.

Documentation and Traceability

Customer-Specific Documentation: 

We deliver documentation tailored precisely to your requirements.

Full Traceability: 

We maintain detailed records of materials, processes, equipment, and operator qualifications.

Test Coupons Archiving: 

We archive test coupons from every production lot for future reference.

Qualified Personnel and Equipment

Certified Operators: 

Only qualified operators handle your products, with every process step for implants requiring a double signature.

Validated Equipment and Processes: 

Our equipment and processes undergo thorough qualification through IQ, OQ, and PQ validations, ensuring the highest standards of performance and reliability

Ensure Consistent Quality for Your Medical Devices

Partner with GS for flawless PCB production, upholding the highest standards and ensuring integrity without unauthorized changes. Contact us to discover how we ensure consistent quality for your medical devices.

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