The regulation of medical devices, IVDs, In-house IVDs, Software as a Medical Device (SaMD), Diagnostics, AI, and Combination Products is very complex. All products, depending on their intended use and risk classification need to undergo an appropriate regulatory assessment and approval process before it can be marketed.
It is vital to choose the correct pathway or pathways for your product or product family. There are many factors that need to be considered, including the type of medical device, its risk classification, your company’s choice, and order of regulatory jurisdictions to enter, whether you intend to be the legal manufacturer, sponsor, or contractor and whether you need your own Quality Management System (QMS).
Pathways may be sequential or parallel. The choice of strategy is difficult and often depends on cost, ease of approval and need for return on investment. This is especially so for start-up companies and academic institutions seeking translation of research into commercial products.
The DevDx team has a successful track record of navigating the increasingly complex and evolving regulations, standards, guidelines and QMS requirements. We have worked across all types and classifications of medical devices, IVDs, diagnostics, SaMD, and algorithms (AI).
We choose the correct pathway and most timely and cost-effective solutions to bring your product to market as soon as practical. We can either collaborate with or mentor your team or work independently. We work with the TGA, FDA, Notified Bodies, Competent Authorities and Regulatory Agencies.
DevDx has a keen interest in assisting start-up companies and has an excellent record of implementing and achieving regulatory approvals with minimal complications.
Irrespective of where your product is at in its development life cycle, our starting point is usually to develop a regulatory pathway report or undertake a gaps analysis (for legacy products). This report includes the product’s classification for each market, evaluation of appropriate regulatory pathways, potential hurdles or challenges, timelines, and costs.
Our services:
- Global regulatory strategies - AU, US, EU
- Implementation of regulatory strategies leading to CE, Conformity assessment, and US approvals
- Regulation of In-house ( Laboratory-Developed Tests) IVDs
- SaMD and Clinical Decision Support Software (including potential exemptions)
- Compilation of Technical Documentation to support main regulatory jurisdictions
- User requirements workshops
- Risk analyses
- Selection and management of Notified Bodies
- Internal auditing of Technical Documents prior to audit
- Post-market regulation and compliance
- Acting as Person Responsible for Regulatory Compliance (including post-market vigilance)
- AI curated regulatory intelligence updates to secure ongoing compliance to changing regulations, standards and guidelines of relevance
