Quality Assurance

Nothing matters more than quality

Quality is paramount in medical innovation. Delaying documentation and dividing the work among multiple partners is a recipe for disconnect, inefficiency and compromises. Because we can manage the entire process for our partners, we have a unique line of sight into each service area and can proactively deliver quality services and compliance documentation for our clients at every stage. We believe in doing things right, even when it’s harder, because what we are developing together is too important to sacrifice or compromise on quality.

Quality Assurance Capabilities

  • Global QMS Implementation and Support
  • Integration of production QMS with customer quality deliverables for maximum efficiency
  • Internal/External Audit Execution and Management
  • Certified to ISO 9001:2015 and ISO 13485:2016, with multiple FDA registrations and MDSAP certifications and successful audits on record

Related Case Study

Turn your idea into a life-changing innovation by contacting our team today.