Our Quality Policy
We are dedicating to providing safe and effective products and services that will meet both regulatory and industry standards through compliance to our Quality Management System, utilizing state of the art technologies whenever possible, and our corporate program for Quality, Delivery and Cost (QDC) to help improve the quality of life and health for the patients and clinicians whom we serve.
Our Commitment Through Our People and Our Processes
Global compliance and continuous improvement are foundational. We strive for continual improvement of our products, services and processes and incorporate both international and third-party auditing to assist in the review of our systems. In addition, we ensure:
A diverse team with solid quality assurance experience for medical and non-medical products.
Compliance to international standards (ISO/FDA) and best practices (GMP).
Consistent Quality Management System (QMS) directing our global operations.
Strict adherence to production planning and document controls such as Device Master Record (DMR), Device History Records (DHR) and change controls.
Management of all supplier partnerships.
Total Quality Management (TQM) in manufacturing processes.
Global Regulatory Registration and Compliance
Our Quality Management System is incorporated at all our facilities and follows the highest international standards, such as:
ISO 13485:2016 Medical devices – Quality Management Systems
ISO 11135:2014 Medical Devices – ETO Sterilization Systems
EU Medica Device Regulation (MDR) – Compliant to MDR Regulations
CE Certified – Various Devices for MDD93/42/EEC (CE) Conformity
EN 13795 – Compliant for Medical drapes and gowns
ANSI/AAMI PB70 – Liquid Barrier Performance and Classification of Protective Apparel and Drapes in Health Care Facilities
Personal Protective Equipment Directive (EU) 2016/425 MODULE D – Non-Medical Protective Apparel
MDSAP Certified – Medical Device Single Audit Program QMS for Australia TGA (Regulations 2002, Schedule 3, Part 1), Health Canada (Medical Device Regulations SOR/98-282, Part 1), and USA FDA (21 CFR Parts 803, 806, 807, 820)
FDA Registered as a Manufacturer, Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Repackager/Relabeler