quality and
regulatory.
Solutions from advice, to a full undertaking of responsibilities so you can use your time where
it matters most.
Establishing then managing in-house regulatory
affairs is a costly and time-consuming part of
med tech commercialisation. Consultants will
only help with part of the journey.
Actis Medical are different because they will carry
out your regulatory obligations. Your company,
your product and your expert partner Actis Medical
at the helm of your commercialisation duties.
Implementation and management of
ISO13485 Quality Management Systems.
- e-QMS setup and Maintenance
- Patient Specific Quality Management Systems
- ISO 13485 and ISO 14971 compliant
- TGA and FDA quality system regulations (QSR)
- Risk Management (Process and QMS Risk)
and Quality Auditing - Management of ARTG & Prostheses List applications
- We implement the quality system to make it work
for you and your business.
All elements of regulatory affairs
for Class I—III devices including:
- TGA Conformity Assessment (Class I – III)
- CE Mark (MDD 93/42/EEC & MDR Regulations)
- FDA 510k
- Patient Specific / Matched Devices TGA, EU, USA
- Successful regulatory applications in 15 different
countries helps ensure you get certification.
1. Design and Development
Engage with our design engineers to take your product from concept through the design and development process ready for manufacturing.
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2. Manufacturing
Transform your design concept from prototype into a market ready product using appropriate manufacturing methods. We offer contract manufacturing which...
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3. Validation and Performance
Regulatory Authorities such as the TGA and FDA require comprehensive performance data to approve a medical device application. Actis Medical...
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5. Commercialisation
Access to local and international markets. Our specialists have a strong track record with sales distribution channels in Australia, Europe,...
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