Quality & Regulatory

All of GRI-Alleset’s products are under the full auspices of and manufactured by our parent company: Global Resources International, Inc. (GRI).

We subscribe to continuous improvement methodologies to improve our processes, and use both international auditing and 3rd party audits to help us review our systems and effectiveness on a regular basis.

Quality Assurance

Policy

Provide products and services in consistent compliance with our clients, quality and regulatory system requirements.

Program

  • 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.

Regulatory Compliance

GRI utilizes the most stringent protocols required by the healthcare industry in all aspects of our manufacturing processes. Our Quality Management System is in compliance with the highest international standards, such as:

International

  • ISO 13485:2016 Medical devices – Quality Management Systems
  • ISO 11135:2014 Medical Devices – ETO Sterilization Systems

Multi-National

  • 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)

North America

  • FDA Registered as a Manufacturer, Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Repackager/Relabeler

Europe

  • EN 13795 – Compliant for Medical drapes and gowns
  • CE Certified – Various Devices for MDD93/42/EEC (CE) Conformity
  • Personal Protective Equipment Directive (EU) 2016/425 MODULE D – Non-Medical Protective Apparel

Asia Pacific

  • CFDA Facility and Product registered – China; Approval Process for Medical Devices (Regulation YY/T 0287)
  • TGA – Australia; Approval for Surgical Drapes and Gowns
  • Foreign Medical Device Manufacturer – Japan; Article 23-2–4 of the Act on Pharmaceuticals and Medical Devices