Zinexts Pursues Medical Device Excellence: BSI Accredited ISO 13485 Certification Achieved
As Zinexts evolves from an instrument and reagent manufacturer into an integrated diagnostics solutions provider—bridging molecular testing, genomics, and data-driven clinical insights—regulatory compliance and organizational credibility become strategic assets central to our vision of Medical Device Excellence.
In this context, we transitioned our ISO 13485 certification to BSI, an internationally recognized authority in medical device conformity assessment, to ensure our Quality Management System reflects the rigor expected in regulated clinical environments.
ISO 13485 vs. Accredited ISO 13485: A Substantial Difference
ISO 13485 Certification
- Confirms that a company’s Quality Management System meets ISO 13485 requirements often perceived as ticking boxes of regulatory obligations.
- The certificate is issued by a certification body.
- However, the certifying body itself may not be accredited, meaning its competence and rigor have not been independently validated.
Accredited ISO 13485 Certification
- Represents the highest level of conformity assessment.
- The certification body—in this case BSI—is accredited by internationally recognized authorities (e.g., ANAB, UKAS).
- Accreditation verifies that the certifier is competent, impartial, and authoritative in evaluating medical device manufacturers.
By earning BSI Accredited ISO 13485 Certification, Zinexts is fully aligned with the global expectations from medical device and diagnostics manufacturers and signals readiness for the regulatory pathways associated with clinical adoption. In regulated markets, this distinction is strategic: it lowers registration barriers, accelerates OEM partnerships, increases tender competitiveness, and strengthens trust with laboratories, ministries of health, and regulatory agencies.
