KD&A provides flexible retainer services for medical device and IVD manufacturers and sponsors who require ongoing Quality Management System (QMS) and regulatory support across Australia and global markets.

Our retainers give organisations access to experienced regulatory and quality specialists who work alongside internal teams to manage day-to-day compliance activities and strategic regulatory decision-making—supporting post-market obligations, certification maintenance and portfolio growth.

Drawing on decades of industry and regulatory experience, KD&A tailors retainer arrangements to your organisation’s size, product portfolio and regulatory footprint. Services typically include QMS maintenance, audit readiness, Technical File updates, regulatory change monitoring and regulator engagement.

FAQ 1: What are regulatory retainer services?

Retainer services provide ongoing, embedded regulatory and QMS support through a monthly allocation of hours or agreed scope, allowing organisations to manage compliance activities consistently rather than reactively.

FAQ 2: What activities can be covered under a retainer?

Retainers can include:

• QMS maintenance and optimisation
• Internal audits and audit support
• External audit readiness and attendance
• Training programs
• Change management
• PMS and vigilance support
• Technical File updates
• Regulatory decision-making
• Regulator correspondence

FAQ 3: Are retainers suitable for growing or early-stage companies?

Yes. Retainers can be tailored for start-ups building regulatory infrastructure as well as established manufacturers managing complex portfolios or multiple jurisdictions.

Why retainer support matters

An ongoing regulatory partnership:

• Provides predictable access to expertise
• Supports consistent compliance
• Reduces regulatory risk
• Improves audit readiness
• Enables faster strategic decisions
• Keeps organisations informed of regulatory changes