Our Baltum Bureau team, together with our partners can help you in matters of Medical Certification.
ISO 13485 certification is a quality management system (QMS) standard for the medical device industry, developed specifically for the manufacture of medical devices.
The standard is based on the ISO 9001 process model approach and provides a framework for managing the production of medical devices.
ISO 13485 is used by organizations involved in the design, production, installation, and servicing of medical devices and related services, and can also be used by internal and external parties such as certification bodies during their auditing processes.
Certifying your company’s QMS to ISO 13485 involves implementing all of the requirements in the ISO 13485:2016 standard and having auditors from an independent third-party certification body verify that your QMS processes meet all of the requirements of the ISO 13485 standard.
Certification training for process owners, internal audits, and the standardization of processes and necessary records are all steps that can be taken to prepare for the certification process.
ISO 14155 is an international standard that provides the general specifications and requirements for clinical investigations. The standard is intended to protect the rights, safety, and well-being of human subjects and ensure the scientific conduct of clinical investigations and the credibility of the results. The Voluntary Clinical Certification Scheme (VoCCS) is a program designed to evaluate compliance with Good Clinical Practice (GCP) principles according to ISO 14155. This scheme focuses on clinical quality management (CQM) and enables the audited service provider to deliver state-of-the-art services.
With an ISO 14155 certification, an organization can demonstrate its commitment to protecting the rights, safety, and well-being of human subjects and ensuring the scientific conduct of clinical investigations.