In Australia, software that meets the definition of a medical device is generally regulated by the Therapeutic Goods Administration (TGA). However, not all health‑related software is subject to full regulatory oversight. The Therapeutic Goods (Excluded Goods) Determination 2018 sets out circumstances where certain health‑related software is excluded from regulation as a medical device in Australia. […]
The Model Code of Practice: Managing the risks of biological hazards at work provides practical guidance for employers in cleaning, security, land remediation, and public spaces to protect staff from biological hazards like viruses, bacteria, parasites, and mould. These hazards exist in all workplaces and can cause illness or injury, especially for those working closely […]
Reframing Risk as a Strategic Planning Tool While risk is typically associated with negative outcomes, at Distinct Compliance Engineering, we embrace it as a valuable management tool. As more organizations adopt management system certifications (Quality, OHS, Environmental) and standards align with ISO’s Annex SL, we’re seeing increased focus on implementing effective risk management principles. Risk […]
If you import, manufacture, or sell electrical devices in Australia, you’ve likely encountered: EESS (Electrical Equipment Safety System) ACMA (Australian Communication and Media Authority) requirements Electricity Safety (Equipment Safety Scheme) Regulations Navigating these requirements can be challenging, especially with recent regulatory changes. Many organizations struggle with: Properly classifying their equipment Understanding applicable standards Meeting EMC […]
In the medical device world, Usability Engineering (IEC 62366 – The application of Usability Engineering or its 60601 counterpart IEC 60601-1-6) is a required tool within the validation of a medical device. Regardless of whether it’s software, active, or IDV, Usability Engineering helps us understand how the device (or system) performs in real-world applications. Risk […]
The current economy makes turning to China for goods worthwhile. Even with manufacturing and custom parts, Chinese organizations are more than willing to accept low MOQs to increase trade. All these factors make it appealing for smaller businesses (and large ones alike) to source from China for services and goods. However, there are important considerations […]
Understanding ISO 9001 Certification ISO stands for International Organization for Standardization. ISO is an official governing body for quality management systems standards across the globe. ISO 9001 is open to any business in any industry, from small to large scale. Subscribing to an ISO9001 management system shows your clients that you follow a set of […]
There are many inherent benefits of being certified to a Quality Management System (QMS). It shows regulators and customers alike that your business takes quality seriously and you have the tool kit to understand requirements, control your processes, deal with issues, and continually improve your products and services to exceed their expectations. Our blog post […]
Adopting a management system is of utmost importance for every business to acquire a leading position in the marketplace. Having no standard certification means you are doing business without defining your goals and objectives. Hence, having no direction to lead to. Currently, ISO 9001 seems to get all hype among the organizations to help them […]
Today the concept of “internal audit” is widespread in business. Many large enterprises and companies prefer to create their own internal audit services and departments, training their employees. Besides, there is a constantly growing demand on the labor market for specialists who possess relevant knowledge and have an international diploma. Tasks of the internal audit […]
