We are pleased to announce that Qualiteam s.r.l. has achieved certification to ISO 13485:2016, the international standard for quality management systems specific to medical devices.
This certification confirms that our Quality Management System meets the requirements defined by International Organization for Standardization for the design, manufacture, and distribution of non-sterile postoperative supports and medical garments.
While ISO 13485 is increasingly an expected standard in our sector, it is not a regulatory requirement for Class I, non-sterile, non-measuring, non-invasive medical devices.
For us, this was therefore a deliberate step taken to further formalize our existing processes and strengthen our role as a reliable manufacturing partner.
What ISO 13485:2016 Means
ISO 13485 is the globally recognized benchmark for organizations involved in the medical device lifecycle. Certification demonstrates that a company has implemented structured, controlled, and traceable processes covering:
• Design and development
• Supplier qualification and purchasing controls
• Production and process control
• Product identification and traceability
• Complaint handling and corrective actions
• Risk-based decision making
• Ongoing monitoring and continuous improvement
Achieving this certification is not a one-time exercise. It requires consistent application, documented evidence, internal audits, and regular management review in line with regulatory expectations.
Scope of Certification
The ISO 13485:2016 certification applies to the following scope:
Design, manufacture and placing on the market of non-sterile postoperative supports and medical garments.
This scope reflects Qualiteam’s core activity and aligns with the requirements of the EU Medical Device Regulation (MDR 2017/745), under which our products are classified and marketed.
Why This Matters to Our Partners and Customers
For hospitals, distributors, and healthcare professionals, ISO 13485 certification provides objective assurance that:
• Products are developed and manufactured under controlled conditions
• Regulatory requirements are systematically identified and met
• Quality and safety are embedded into daily operations, not added afterward
• Feedback and complaints are handled through defined and auditable processes
• Continuous improvement is an explicit management responsibility
For international partners, this certification also supports smoother regulatory interactions in markets where ISO 13485 is expected or required as part of product registration.
A Milestone, Not a Finish Line
For us, this ISO 13485 certification formalizes practices we already consider essential: discipline, accountability, and consistency in how we design and deliver products intended for patient care.
Quality at Qualiteam remains a shared responsibility across the organization, supported by documented procedures, trained personnel, and a risk-based approach to decision making. Our Quality Management System will continue to evolve as regulations, markets, and customer expectations develop.
We thank our team, partners, and distributors for their continued trust and collaboration.
Download our ISO 13485 certificate here.
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