QMS

The much anticipated amendment to EN ISO 13485:2016 has now been published in the form of A11:2021, providing manufacturers with updated Annexes ZA and ZB to reflect the obligations and requirements of the new EU Regulations for medical devices and IVDs. The EU Regulations clearly stipulate that all medical device manufacturers shall have a Quality … Read more

Regulation (EU) 2017/745 (MDR) requires manufacturers of devices, other than investigational devices, to establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and such that it is proportionate to the risk class and the type of device. … Read more

ISO13485:2016 is the most recent version of quality management system (QMS), specifically for medical device manufacturers and is now considered the ‘gold’ standard. Manufacturers have until March 2019 in order to update their current ISO13485 QMS to this latest version and become certified. In addition if it’s your intension is to access USA, Brazilian, Japanese, … Read more

This announcement was issued by the ACTIV providers, those who use this system should have now noticed the changes and the reports we have are very positive: In October we’ll be refreshing Activ to give it a more modern look and feel. Along with the new styling, the main change you’ll notice is the improved … Read more

Quality Management System In relation to the Quality Management System [QMS] the OBL will be expected to maintain a QMS which covers the requirements as defined in the Medical Device Directive or IVD Directive as relevant. This does not mean that a fully compliant ISO13485 system must be in place although if this is the … Read more

Training and managing personnel information plays a vital role in the success of a quality management system. Once trained and skilled, your employees not only ensure the quality of products and services delivered but also work to ensure that the organisation is compliant with industry regulations. This simple ACTIV web-based application was designed so that … Read more

All of the following points should be considered in relation to the new legislation: a). There is a high emphasis on the need to audit the premises of the (legal) manufacturer and also critical subcontractors and suppliers. This will lead to the need to visit all manufacturers annually including own brand labellers and to increased … Read more

Here at,  Advena Medical Ltd, we firmly believe that a smooth transition to a digital – paperless document workflow can set up an organisation for success, which is why we’ve developed an in-depth QMS System called ACTIV to assist our partners as they make the switch. We have noticed that more and more organisations are switching … Read more

QMS can help your business to: 1) Achieve greater consistency in the activities involved in providing products or services. 2) Reduce expensive mistakes. 3) Increase efficiency by improving use of time and resources. 4) Improve customer satisfaction. 5) Market your business more effectively. 6) Exploit new market sectors and territories. 7) Manage growth more effectively … Read more