Hydrix’s regulatory, clinical, product design and development offering is
de-risking and accelerating technology commercialisation
Recent projects that illustrate the value delivered:
National Medical Products Administration (NMPA) gap analysis for a Class III product entering the Chinese market
Instrument and consumable development, regulatory strategy, development of QMS, pre-submission planning and submission preparation for a Class IIb IVF product (TGA, FDA and EU)
Product development, regulatory strategy, development of QMS, clinical trials management and submission preparation for a Class IIb orthopaedic product (TGA, FDA and EU)
Medical Device Register (MDR) gap analysis for a Class III product currently being sold in the European market
A full range of services tailored to suit your needs
We have tailored our services to suit medical developments with different levels of maturity and projects of a variety of scope and complexity. Our integrated approach helps our global clients overcome regulatory hurdles, assisting from one regulatory milestone to the next, reducing risks and facilitating compliance on the way towards a successful submission.
> REGULATORY STRATEGY
Increasingly complex regulatory requirements and rapidly evolving technology can create headaches for medical device developers. Our regulatory consulting team is a unique resource in managing this complexity, through strategic guidance and input into the product development process, leading to more a mature regulated product, and increasing the opportunity for better compliance outcomes. We can achieve these outcomes by:
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Regulatory/clinical/reimbursement strategy development for global markets including: US, Europe, Canada, Japan, China, Australia, and APAC countries
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Regulatory gap analysis and preparation of mitigation plans prior to regulatory submission
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Regulatory assessment to address changes in regulatory requirements and standards
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Facilitating premarket engagement with regulators
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Rapid pivot to address post-market issues and interactions with regulators
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Develop regulatory and administrative appeals strategy
> TRAINING PROGRAMS
Have recent interactions with medical device regulators identified some gaps in your knowledge? If so, our experienced regulatory consulting team can deliver training to help develop the skills necessary to avoid common pitfalls, understand regulatory requirements and develop clinical evidence to support business needs (product development, regulatory, marketing and reimbursement).
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TGA Sponsor Requirements
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Compliance with TGA Essential Principles/EU Essential Requirements – General safety and performance/General health, safety and performance
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Overview of regulatory frameworks (US FDA, Japan PMDA, Health Canada, EU CE mark, Australia TGA, China NMPA, Singapore HSA, and other APAC markets)
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Clinical evidence overview
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Creation of technical files/design dossiers/STED/DHF/DMR
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Compliance with ISO 13485 QMS
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Risk management in compliance with ISO 14971 during product development
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Post market process overview (AE, PMS, recalls, reporting)
> AUSTRALIAN TGA MEDICAL DEVICE SPONSORSHIP
If you are an overseas company with no registered business in Australia, you need to appoint a local Australian sponsor for compliance to both medical device regulations and registration. Our regulatory consulting team can act as your Australian medical device sponsor to meet and show compliance with Australian TGA Medical Device and IVD Device Regulations and the Therapeutic Goods Act. Our post-market regulatory support ensures you meet Australian regulatory requirements. Working as part of your team we can:
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Submit Manufacturers Evidence
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Apply for inclusion of the product(s) on the Australian Register of Therapeutic Goods (ARTG)
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Fulfill post-market reporting to TGA
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Incidents, adverse events and near misses
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Overseas regulatory action
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Manufacturer investigations
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Annual reporting (Class III, AIMD, or Class IIb implantable)
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Strategies to implement CAPA and facilitate TGA close-out
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Provide product distribution and management services in line with regulatory requirements
> MARKET ACCESS
Our experienced regulatory consulting team assists our global clients overcome regulatory hurdles, reducing risks and facilitating compliance to achieve a successful submission. To streamline market access, we can:
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Assistance with application processes
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Create or review your technical documentation/design dossier/STED/DHF/DMR/QMS to ensure compliance with regulatory requirements
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Create or review your Clinical Evaluation Report
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Develop documentation for regulatory and administrative appeals
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Complete your Declaration of Conformity
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Provide preparation and support for onsite audit
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Medical device reimbursement applications with public and private payers
Case Study
Combining design development and regulatory services
Development of the GYDER™
Gyder Surgical, a Melbourne-based start-up, is developing a novel medical device to assists surgeons to accurately position the acetabular cup during hip replacement surgery. Hip replacement is one of the most common inpatient procedures in developed economies. Currently, many surgeons perform this ‘navigation’ freehand, which leads to an average of only 50% alignments being correct. The GYDER™ addresses this issue with a fast, simple to use, non-invasive, low cost, intra-operative surgical navigation tool suitable for Minimally Invasive Surgery (MIS).
In partnering with Hydrix, Gyder Surgical, is taking advantage of having R&D plus regulatory and quality systems skills all within the one company. This decision has allowed Gyder Surgical to rapidly mature its technology and prepare for market launch.
“Hydrix combined offering of design engineering capability, coupled with quality and regulatory specialists, has enabled Gyder Surgical to access all the skills that a start-up needs in the development phase, without the overhead and challenges of hiring additional staff or managing multiple independent consultants.”
Bill Hill
Director, Gyder Surgical

Have a project with regulatory requirements? Contact us to explore how we can help you navigate your product development journey.