Welcome to ORA innovations.

December 14, 2017

We will be bringing you regular business updates via our blog. But for our first post, some exciting announcement.

Our first big news - ORA website is undergoing an update! That's right, our team have been working on developing a fresher, cleaner look for the website and we're very close to launching, so stay tuned.

 

The second great news - we have two new members in our team. Keren Natalia and Belinda Tupou - and of course you all have met Linda.

 

Keren Natalia is a quality and medical device expert with over 10 years experience in the field. She has extensive experience working with GMP certified facilities, medical instruments, implantable devices, IVDs, Biologics, Telehealth, High Level Disinfection and many more.

 

Belinda Tupou is our in house marketing guru. Belinda migrated from New Zealand to Australia in 1993 and is a marketing professional with twenty years extensive experience in senior marketing and corporate affairs.

 

Linda Allwork is ORA innovation’s Quality Consultant of almost 5 years. She is a certified auditor for ISO 13485 and ISO 9001.​Her previous corporate roles include Industrial Engineer in the international freight industry; and an I.T. Project Manager in software engineering, development and Quality Assurance.​

 

On the regulatory front, new EU Regulations have been released. The previous three Directives on medical devices have been replaced by two Regulations on medical devices and in vitro diagnostic medical devices. The new Regulations promised to build a more patient-friendly environment, as well as tightening the controls to ensure that medical devices are safe and effective. The new Regulation also contain changes to foster innovation and address future challenges, taking into account the latest developments in the sector (medical software, apps, cybersecurity).

 

More information and update on the development in the medical industry to come. Watch this space. We will also be issuing newsletter for major events and training session so make sure you subscribe to our email list

 

 

 

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ORA innovations boasts over 30 years of combined experience in Quality Management Systems, Compliance, Project Engineering, Product Development, Auditing, Training, New Product Introduction, Documentation and Manufacturing for diverse industries from Electronic Equipment, to Medical Devices and Pharmaceuticals.

With a wealth of experience in Implementing, Auditing and Managing Quality Management Systems ORA innovations has led a number of Medical Devices Companies to achieve their certification to ISO13485, CE Mark their products and others to ISO 9001.

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