ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.
PCMS having the team of Auditors and Technical Experts who can conduct a value added Audit and contribute in the continual improvement of your organization. PCMS team can provide the two step audit and you are entitled for the certification of ISO 13485:2016 which is required by your customer or in tender purpose.