Medical Devices

Medical Device Consultants Engineering related medical device consultants can come from a lot of different areas. These span from science degrees like microbiology and physics, innovation degrees such as product design and implant design and also a range of engineering degrees – primarily mechanical and biomedical. There are different grades of Medical Devices depending on…

With the Olympics still fresh in our minds, it seems fitting that the TGA announced their race times for the complete implementation of ISO 13485:2016 certification as opposed to ISO 13485:2003 acceptance. On your marks… In a recent blog, Custom Medical Devices TGA / ISO 13485:2016 Certification, we discussed the benefits and requirements of implementing…

Do I really need ISO 13485:2016 certification? There has been rapid growth in the area of custom-made medical devices, made for single known, patients and this has led to the authorities issuing additional guidance. Innovative companies around the world are producing devices and drugs such as Anatomics and Aprecia* using technologies such as 3D printing. *Note: In March 2016,…

PharmOut recently developed a free ISO 13485:2016 Gap Analysis tool for identifying the gap between the ISO 13485:2016 and ISO 13485:2003, currently this tool is free to all clients attending our ISO 13485:2016 Medical Device training, or anyone that may have previously purchased our ISO 13485:2003 QMS templates since the 1st January 2016. The latest…

Seamus Orr Lead Consultant, offered the first ISO 13485:2016 training in Australia and New Zealand, now we are offering ISO 13485:2016 Templates for sale, our customers describe the templates as follow – “Your templates are the most high-level (as well as attractive and professional looking) of all the templates I am finding online. They are nearly double…