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ISO 13485:2016 is designed specifically for medical device companies and recognised worldwide as the quality management standard. ISO does not perform certification audits or issue certificates. This is carried out by a notified body or registrar. Therefore certification automatically improves the perception of your company and its products and is required for product marketing in most countries. The idea behind ISO standards is to make the quality management system clear by showing how company processes relate to ISO 13485:2016 standards. This can be best achieved by appointing a quality management consultant to act on your behalf to ensure you have Continue reading →

4. Systemic requirements 4.1 Organisational requirements 4.1.1 Develop a QMS 4.1.2 Clarify structure 4.1.3 Support processes 4.1.4 Manage changes 4.1.5 Control outsourcing 4.1.6 Validate software   4.2 Documentation requirements 4.2.1 Manage information 4.2.2 Prepare manual 4.2.3 Establish files 4.2.4 Control documents 4.2.5 Maintain records 5. Management requirements 5.1 Commitment requirements 5.2 External requirements 5.3 Policy requirements 5.4 Planning requirements 5.4.1 Establish quality objectives 5.4.2 Carry out quality planning 5.5 Managerial requirements 5.5.1 Clarify responsibility and authority 5.5.2 Appoint management representative 5.5.3 Establish internal communications 5.6 Review requirements 5.6.1 Perform regular management reviews 5.6.2 Study management review inputs 5.6.3 Generate management Continue reading →

 Having a quality management system based on ISO 13485 standards at an early stage can help gain regulatory approvals from a variety of EU countries. Quick certification can mean quicker access to markets. The longer medical device manufacturers stay in the review stage, the more costly dealys to market become. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market. Benefits of ISO 13485 for medical device manufacturers: Increases customer confidence Certification establishes a company’s commitment to quality, which often leads to increased customer confidence Improves marketing Continue reading →

Summary ISO 13485 certification can open doors to European business opportunities and help build confidence with clients, investors and employees. The 2016 update places greater emphasis on risk management and risk-based decision-making for processes outside of product realisation. The focus is on risks associated with safety and performance of medical devices and compliance with regulatory requirements. The standard can help manufacturers build their reputation, speed up product launches and reduce number of product recalls and costly regulatory sanctions. What is ISO 13485? ISO 13485 is an internationally agreed standard that sets out the requirements that help medical device manufacturers develop Continue reading →