Amferia Strengthens Advanced Wound Care Platform with ISO 13485 Quality Certification
The certification reflects Amferia’s commitment to quality throughout the product lifecycle and complements the company’s recent FDA De Novo clearance, providing a robust foundation for the manufacture and commercialisation of high-quality peptide-based antibacterial wound care products.
Amferia, the Swedish medtech company whose antibacterial peptide-based wound dressing recently received the first FDA De Novo classification issued in its category in over a decade, has now earned ISO 13485 quality certification.
The quality certificate, issued by a certification body after a comprehensive audit, is a credible signal that the company’s operations now meet the highest quality standards for medical devices.
The ISO certification confirms that Amferia has established and maintains a documented quality management system (QMS) covering the full product lifecycle: design and development, production, documentation control, risk management, post-market surveillance, and complaint/CAPA handling. The certification further verifies that Amferia operates with patient safety and regulatory compliance as its governing principle.
“ISO 13485 certifies that we can build, deploy, and support the products our discoveries enable at the highest quality,” said Anand Rajasekharan, Amferia CEO & Co-Founder. ”We developed the technology, demonstrated its efficacy, protected our IP and received FDA De Novo grant. The next step was to certify to all our stakeholders that we can produce quality products. This certification verifies that we’ve done that.”
“Achieving ISO 13485 certification is a major milestone in our journey as a growing company. It demonstrates that we have built a strong foundation of quality, compliance, and accountability from the start. For our customers, partners, and stakeholders, this certification provides confidence that we are committed to meeting the highest standards as we continue to innovate and scale” said Therese Rydell, Amferia Director of Quality and Regulatory Affairs.
ISO 13485 is the internationally recognized quality management system standard for medical device manufacturers. It provides a framework for meeting regulatory requirements and is widely recognized as the foundation for quality management compliance under regulatory frameworks such as the EU Medical Device Regulation (MDR) and the U.S. FDA Quality Management System Regulation (QMSR).
ISO 13485 certification is a important milestone for Amferia, demonstrating that its quality management system meets internationally recognized standards for risk management, process control, and traceability throughout the product lifecycle. For potential partners the certification provides independent validation of the company's commitment to quality and regulatory compliance, while supporting its ability to scale operations and bring innovative medical devices to market.
About Amferia
Amferia is a Swedish medtech company developing advanced antimicrobial wound care products based on a proprietary nanostructured hydrogel platform. Amferia continues to expand its product pipeline, invest in research, and collaborate with global partners to redefine how infections are prevented and managed. By stabilizing one of nature’s most effective bacterial defenses, the company offers a transformative platform with the potential to strengthen antibiotic treatments and improve outcomes across healthcare.
Contact
Anand Rajasekharan
CEO & Co-Founder, Amferia
+46 76 298 12 38
anandk@amferia.com