Regulatory & Compliance

Healthcare and med-tech companies face stringent oversight from regulators such as the TGA, MHRA, FDA, EMA, and data-protection authorities.

Typical support includes:

• Product classification and regulatory pathway advice (medical device, digital health, software as a medical device).
• Compliance with health-specific regulations (e.g., TGA, FDA 510(k)).
• Advertising, labelling and clinical claims review.
• Post-market surveillance and adverse-event reporting obligations.
• Interactions with regulators and responding to audits or enforcement action.

At Lodestar Legal, we help businesses navigate the complex and ever-changing world of regulation with confidence. Whether you operate in a heavily regulated sector or are scaling a new product that touches on emerging compliance requirements, our team provides the legal clarity you need to operate securely and strategically.

We work closely with clients to identify their regulatory obligations, design practical compliance frameworks and respond effectively to scrutiny from regulators and other stakeholders. Our lawyers combine legal expertise with commercial understanding to deliver advice that is not only technically sound but also aligned with your business objectives.

Our services include advising on licensing and authorisations, governance structures and internal compliance programs. We assist with regulatory reporting, investigations and audits, helping clients prepare for – and respond to – regulator engagement with professionalism and precision. For businesses facing enforcement action, we provide robust representation and negotiation support to manage risk and protect reputation.

Lodestar Legal also supports clients in embedding compliance into day-to-day operations. From drafting policies and training materials to advising boards and senior management on their legal responsibilities, we ensure your organisation remains proactive, not reactive, in managing regulatory change.

With deep experience across sectors such as healthcare, med-tech, technology financial services and professional services, Lodestar Legal delivers the insight, foresight and strategic advice needed to keep your business compliant and competitive.