Quality Compliance

Successful medical companies distinguish themselves from competitors through new and innovative solutions. The result is effective and efficient products.

When companies bundle such efficiencies with improved equipment through intelligent quality assurance, outcomes are then obvious. These include the elimination of flawed products from production lines and decreased production costs. The ultimate gain will be for the patient, receiving a product at a competitive price and at the highest possible quality.

ISO13485 is a key milestone achievement for the industry. This standard has evolved over time since its introduction in 2003, to what has become one of the most referenced documents in the process of establishing a continuous and improving Quality Management System.

The phrase Quality Management System really means that a company that has embraced the elements of ISO13485 has an established system that is continuously managing and improving its product’s quality.

The elements forming the backbone to ISO 13485 are simple.

They are a culmination of a number of documents capturing the validated status quo of multiple processes used to build a product. In other words, a baseline of information, or that starting point to that objective of continuously improving what you already have.

If my accountability is just to produce and sell a product then I fall short of my assessment of the competitive landscape that will improve on what I have. However if my feedback system from internal and external sources leads me to reviewing my day to day tasks, then the outcome will be the integration of improvements to the lifecycle of my product on a continuous basis.

ISO 13485 is not used only for compliance to regulatory requirements and it is not inclusive and stand alone document. In combination with other standards such as ISO 14971, ISO 11135, ISO 10993, EN 1041, to name a few forms that community of guidance documents required to create that system baseline.
This system that manages your quality is made of the following simple building blocks:

  • The Quality manual that commits to a system
  • Procedures and Instructions, that drives your system
  • Records that substantiate the validity of your system

Its management will ensure:

  • Compliance to regulatory requirements
  • Commitment to continually meeting the needs of the end user
  • Total accountability to all involved in the process

Product Registrations

Our preliminary meeting will form the basis of the regulatory strategy moving forward.

We are most flexible with the initial discussions either by phone conference, at your facility or at our premises.
We will share with you the regulatory landscape for similar products in Australia and will work with you on the most strategic tactical approach for a timely product approval.

We will give you the choice to either ask the right questions to your manufacturer with regards to key product information required for the submission to the Therapeutic Goods Administration or you can leave it to us for total coordination.
You will be given the option of accessibility to our secure website portal for live and up to date project updates.
Our differentiated approach will allow you to download information directly to the secure and company specific portal for our assessment and feedback.

Our e-document system will allow you to retrieve information at most times at a click of one button. Auto monthly reports to your management format can be produced and auto sent to you pursuant to your requirements.