OUR SERVICES.

What We Do

We manage, teach, mentor and guide companies and individuals new to medical device development through the process.

We help grow existing companies to success in new markets, with new technologies, or to expand upon existing product lines.

We do this by supporting the entire lifecycle by managing internal and external relationships, contracts, and work packages. By leveraging our knowledge and past experiences we can remove the unknowns and risks associated with this inherently challenging process of getting medical devices to market.

Our Philosophy

The client comes first. In all that we do we take on your vision, we own it, and project it, to all that work on or are associated with the project. We do this as the vision is the strongest binding mechanism there is on any project. A solid vision will bring cross-disciplinary teams together with a combined focus and energy.

Your success is our success… your vision is our vision.

  • Develop a cross-disciplinary strategy that covers the main areas of medical device development. Clinical, regulatory, development, and manufacturing.
  • Integrate all of the disciplines and streams of work into one cohesive strategy that aligns the internal and external teams
  • Business case development
  • Coaching and mentoring for delivery to strategy and navigating the challenges through the process
  • Oversight and design authority of internal and external development teams
  • IEC62304 Software lifecycle process support/guidance/flow
  • System architecture design – Class III and safety critical design
  • Technology review and due diligence
  • IEC 60601 support and design guidance
  • Objective technical reviews
  • Objective design for test (DFT) reviews, design for manufacturing (DFM) reviews.
  • Manufacturing process reviews and oversight.
  • Electronics, firmware, software and mechanical expertise
  • Verification planning and review
  • ISO 14971 support, facilitation.
  • Risk analysis facilitation, support, review
  • Product and project risk assessments
  • QMS support throughout the medical device lifecycle – when and how much to do at the different stages
  • Program/project management support, coaching and guidance
  • Able to utilise and draw in extensive network of known and trusted experts across regulatory, clinical, commercial, risk, and design, development and manufacturing
  • Program/project management support, coaching and guidance
  • Able to utilise and draw in extensive network of known and trusted experts across regulatory, clinical, commercial, risk, and design, development and manufacturing

MTASK is a medical device development consultancy built around decades of experience in getting devices to market. We are not aligned with anyone product development company or manufacturer as we utilise the skills and expertise of the various groups we know and trust across Australia and globally to deliver what is required for each client. We utilise the strengths of our network to deliver value and success for our clients.

Read More