Quality Management System

Our vast experience in the medical device regulatory field taught us that for a successful implementation and maintenance of a quality management system, the system must reflect the company format, size, culture and means. In other words, the system must be tailored to the company. Therefore, our approach when writing and implementing a QMS is:

• Understand the company goals, mission, policy, markets
• Understand the organization flow and its functions
• Understand the company culture
• Identify the EN ISO 13485 standard / Medical Device Regulations applicable requirements and determine which are already applied and which are not
• Explain the requirements to those in the company who must apply them
• Integrate the missing standard requirements in the company natural processes taking into account the company organization, functions and culture
• Improve our clients’ company’s effectiveness with a minimum increase of “paper work”

Standard ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes is the international quality system standard for medical device companies worldwide, with the exception of the USA (at the moment) which requires 21 CFR 820 Quality System Regulation to be applied.