Bringing a medical device to market should not feel like navigating a maze blindfolded. Regulatory requirements differ by jurisdiction, they change regularly, and the cost of interpreting them incorrectly is measured in months of delay rather than hours of rework.
That is why Compliance Management Solutions and SciDoc Solutions have joined forces, combining more than twenty years of specialist regulatory consultancy each, to create CMS SciDoc.
What the joint venture brings together
Twenty five experts in one team, supporting clients across Australia, New Zealand, Asia, the United States and Europe. From the TGA and the FDA through to EU MDR and UKCA, the combined practice speaks every regulator's language.
- Regulatory strategy and market access
- Technical files and documentation
- ISO 13485 quality management systems and ISO 14971 risk management
- Clinical evaluation support
- MDSAP and regulatory audits
- PRRC and Authorised Representative services
- Post-market surveillance
Led by Dr Esther Apos and George Loizou
The venture is led by Dr Esther Apos and George Loizou as co-directors. Between them the team blends scientific rigour with working regulatory experience, which means clients get a clear pathway rather than a compliance checklist. A checklist tells you what is missing. A pathway tells you what to do about it, in what order, and what it costs to leave it until later.
Based in Melbourne, working globally.
If you are planning a submission, entering a new market, or working out which regulatory pathway applies to your product, please contact our regulatory team to discuss it.