Scapa Healthcare

Quality

Why Scapa?

Quality

We understand that high levels of quality control combined with our commitment to strong manufacturing processes result in consistent, quality products. We have extensively invested in our quality control systems and people. Quality is in everything we do, from expert support, advice and concept design, through full-scale production. You can feel confident that your products are manufactured to the highest level of quality and care.

All of our sites are registered to ISO9001 and ISO13485.

Class 7 (10,000) Clean Rooms

ISO 14644-1:2015 (Europe)

Class 8 (100,000) Clean Rooms

ISO 14644-1:2015 (USA)

FDA Registered

Contract Medical Device Manufacturer

Medical Device Manufacturer

Medical Device Repackager/Relabeler

fda

Certifications

United States

Inglewood, CA

Knoxville, TN

Orangeburg, NY

  • ISO 9001: 2008
  • ISO 13485:2003
  • FDA CFR 21 Part 820                                                                                                     

Windsor, CT 

United Kingdom

Dunstable / Luton

Ramsbury