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ISO 13485 Newsletter

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Our resident ISO 13485 consultants are available to speak with you regarding the steps your company should take next. We understand that sometimes things get confusing, and you need advice you can trust.

More detail and advice in our ISO 13485 Blog

How to choose a consultant for ISO 13485 implementation

If your company has decided to implement the ISO 13485 standard, you might be considering bringing in a consultant to assist with the implementation process. The wise selection of an ISO 13485 consultant is one solution that will greatly increase your chance of success and decrease your timeline in accomplishing accreditation. ...Read more

ISO 13485 structure and requirements

Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 requirements and structure. The standard includes ...Read more

Calibration requirements in ISO 13485

Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485 mean high precision and close monitoring. The manufacture of medical devices makes use of various types of equipment and measuring instruments ranging from simple temperature sensors, weighing balances, pressure gauges, micrometers for measuring dimensions, to ...Read more

Design and development validation and verification according to ISO 13485

Producing any part of a product includes validation and verification in its design and development. ISO 13485 requirements are a great way to start, since it’s targeted specifically to medical device manufacturing. According to the American Society for Quality, the definition of validation in a quality environment is the act ...Read more

How to comply with section 8.2 Monitoring and measurement in ISO 13485:2018

Monitoring and measurement focus on the quality of the product or services, which reflect the effectiveness of the Quality Management System. Simply put, it informs us about whether our products have met the expectations in terms of quality, safety, and efficacy. The ISO 13485 standard defines the different areas in ...Read more

How to comply with the latest changes in ISO 13485 clause 7.2.3 Communication

Communication is considered to be one of the crucial factors in compliance with ISO 13485. Poor communication practices, such as relying on verbal agreements and failing to document changes, could lead to high costs in terms of operational losses. A 2016 survey by the Society for Human Management (SHRM) asked ...Read more

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