In the competitive medical device marketplace, ensuring that product development meets all regulatory requirements is essential. We provide guidance and training to support you through the application process.
We offer a wide range of proven regulatory and quality management programs that work together for full international compliance. Our Quality Management System (QMS) solutions include ISO 13485, ISO 9001, ISO 14001 and many more.
We are a recognized Certification Body in Hong Kong, Japan, Malaysia, Singapore and Taiwan, and a recognized MDSAP Auditing Organization for all participating Regulatory Authorities.
Seamless transfer to BSI
We can offer a seamless service with comprehensive support and the absolute minimum level of disruption.
Certification support and additional services
We offer continual support throughout the certification process and beyond; we also offer:
- access to more than 34,000 standards and related products, as well as online guidance documents
- expert training delivered online or face-to-face, either inhouse or through our public training courses
- regulatory updates and a newsletter service focusing on industry changes, helping you to plan for the future
- webinars delivered by our experts on complex regulatory issues
- comprehensive whitepapers providing the latest insights on key industry topics