Our Services

Advisory

Regulatory pathway strategy: We can help you define a regulatory pathway and understand what work is required to get approval in Australia, US, Europe and other international markets.

Post-market and regulator engagement: Have you got a letter from a medical devices regulator and are not sure how to respond? Are you preparing for a meeting with the regulator? We will advise you on strategy and execution to make sure you get the best outcome you can.

Quality management: Are you new to quality management and want to build your own quality system? We can advise you on interpretation of the regulations and standards and keep you on track.

Engineering: Platypus MedTech is an engineering firm with our own Chartered Professional Engineers, who specialise in biomedical, electrical, and software engineering.

Risk management: Are you unsure on how to run risk management for complex medical devices? We will advise you on building and running risk management systems.

Test and evaluation: Platypus MedTech can advise on the sufficiency of your clinical and engineering testing plans and results against regulatory requirements and standards.

Standards: Platypus MedTech are specialists in interpretation of standards and regulations. We will advise you on how to implement requirements, and whether you need to in the first place.

Consulting

Quality system implementation: Our consulting team will build a compliant Quality Management System that is tailored to your start-up, or small or medium business.

Risk management: Platypus MedTech are experts in risk management systems for health and medical technology. We will build tailored risk management processes for your business and products.

Engineering systems: If you need Design Control, Software Development Lifecycles, Test and Evaluation, or other engineering systems built for you business, our Chartered Professional Engineers will build systems tailored to the standards that you need to conform to.

Internal audits: Are you certified to ISO 9001, ISO 13485, ISO 17025 or ISO 15189, but don’t have capacity to do your internal audits or want an independent auditor? Platypus MedTech can do your internal audits.

Supplier and supply chain management: Platypus MedTech consultants can setup your supplier management systems. We can also support you with supplier assessment and audits.

Training

For groups

Introduction to medical Device regulations
Build-your-own regulatory pathway
Design control for small manufacturers
Assessing and managing suppliers for start-ups and small businesses
Starting risk assessment for your new medical device

Tailored to your team:
Workshops tailored to your own systems or processes.

Supplier management (ISO 9001; ISO 13485; ISO 17025)
Risk management (ISO 14971; IEC 60812)
Design control (ISO 13485)
Post-market monitoring and review (ISO 9001; ISO 13485)
Software development for medical technology (IEC 62304)
Quality management operations (ISO 9001; ISO 13485; ISO 17025)

Platypus MedTech Consultants Pty Ltd
+61 2 6198 3242
enquiries@platypusmedtech.com.au

Level 1, The Realm, 18 National Circuit
Barton, ACT 2600

Platypus MedTech Consulting acknowledges that we live and work on the land of the Ngunnawal, Ngarigo and Whadjuk Nyoongar peoples. We also acknowledge the Traditional Owners of Country throughout Australia where we deliver our services. We recognise their connections to land and waters, the sophistication of First Nations knowledge and their contributions to engineering and science. We pay respect to their Elders, engineers and scientists, both past and present.