GMP, ISO 9001:2015 and ISO 13485:2016 Certifications Announcement!

07 February 2024

Promed Bioscience has been awarded the ISO 9001:2015 and ISO 13485:2016 certifications, marking a significant milestone in the company's commitment to quality and excellence. In addition to ISO certifications, Promed adheres to Good Manufacturing Practices (GMP), a globally recognized standard further attesting to the company's commitment to high-quality, consistent, and safe manufacturing of medical-grade biomaterials.

ISO 9001:2015 Certification: Elevating Quality Management

Acknowledging the company's dedication to delivering products and services consistently meeting client needs, Promed Bioscience has been awarded the ISO 9001:2015 certification. This globally recognized standard underscores the company's commitment to an effective quality management system for enhanced overall performance, high-quality standards, and robust customer service.

This achievement reflects the company's commitment to sustainable development initiatives.

ISO 13485:2016 Certification: Meeting Medical Device Standards

Promed has also been awarded the ISO 13485:2016 certification within the scope of Research, Development, and Production of Raw Materials for Medical Devices (collagen-based biomaterials). This certification, a quality management system standard for medical device manufacturers, demonstrates compliance with regulatory and statutory requirements, supporting adherence to the Medical Device Directive.

The certification process involved a comprehensive evaluation including rigorous evaluation process, including quality management system development, documentation review, and thorough audits, quality management system development, documentation review, audit, and initial assessment. Which is why we chose TUV Austria, a global leader in Testing, Inspection, and Certification, served as a reliable partner, providing independent assurance of Promed's commitment to quality.

Client Benefits of ISO and GMP Certifications

Promed's clients can anticipate a range of benefits, including:

  1. Enhanced Quality Assurance: Products are manufactured under stringent quality control measures, ensuring consistent high quality.
  2. Increased Trust and Credibility: ISO and GMP certifications provide global recognition, reinforcing client confidence in Promed's products and brand.
  3. Greater Regulatory Compliance: Alignment with international regulatory GMP requirements ensures adherence to regulatory standards.
  4. Strengthened Competitive Advantage: Partnering with an ISO and GMP certified raw biomaterial manufacturer elevates clients' brand image, emphasizing a commitment to global standards of excellence.