Implementation of ISO 13485
ISO 13485 is the international reference standard for quality management systems applicable to medical devices. Its implementation is crucial to ensure compliance with European and international regulatory requirements, and it is often a mandatory condition for CE marking and access to markets outside the European Union.
We offer comprehensive consultancy and support services in implementing, maintaining, and certifying quality management systems (QMS) according to ISO 13485, tailored to the specific needs and scale of your organization.
Our services include
Full QMS
Development and implementation of a full QMS, including quality policy, risk management, document and record control, supplier management, corrective and preventive actions, among others
Procedures, work instructions, and mandatory records
Support in drafting procedures, work instructions, and mandatory records, tailored to the company's reality and context
Preparing and assisting with internal and external audits
Support in preparing and assisting with internal and external audits until certification by an accredited body
Maintenance and improvement of the quality system
Ongoing support for the maintenance and improvement of the quality system, ensuring compliance over time and preparation for surveillance audits
