Quality Management System (QMS)

Throughout the lifecycle of the device, we are able to provide a set of policies, forms and procedures for designing, developing and manufacturing medical devices in order to demonstrate compliance with regulatory and legal requirements.

We provide development, implementation, updates and maintenance of a quality management system (QMS) according to ISO 13485 and 21 CFR part 820 used by the company throughout the life cycle of a medical device, from initial conception to production and post-production, covering aspects such as storage, distribution, installation and servicing to establish and maintain the effectiveness of the QMS processes.

Within the QMS, we define a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system.

Assistance with the preparation and updating of a Quality Management System according to ISO 13485.

The main services we provide are:

• Writing policies and procedures
• Preparation and implementation of the Quality Manual
• Implementation of Standard Operating Procedures (SOP) and quality processes
• Internal Audits and Supplier Qualification