VCLS has been selected as one of the experts by BPIFrance to accompany their digital health product start-ups.
De-risk your digital health technology development by applying appropriate regulatory framework at an early stage.
300+ innovative device technologies
From mobile health-related applications, wearable connected devices to Artificial Intelligence (AI), Augmented Reality (AR) and software that supports clinical decisions or monitors patient’s activities, digital health technologies have been driving a revolution in healthcare.
Regulators across the globe are working hard to catch-up with the innovation boom that has been taking place in the last few years. While this was paused due to covid-19 related activity, efforts have quickly picked up again. The short-term aim is to provide guidance to the industry on how such innovative technologies can be developed and assessed using the current regulatory frameworks, whilst working on longer term creative pathways to market and international harmonization.
Currently digital health device manufacturers face a lot of challenges in navigating the regulatory landscape, as most regulations were developed years ago based on more traditional devices, primarily on hardware, that on average have a slower development and release cadence. This challenging environment is exacerbated by changes e.g. due to Brexit or the cessation of the Mutual Recognition Agreement (MRA) for medical devices between Switzerland and the EU.
Key challenge encompass:
- Product qualification/risk classification, including software classification
- Communication with Regulatory Authorities
- Market clearance routes
- Indications for use
- Safety & performance claims
- Risk analysis and risk management plan
- Clinical evidence demonstration, including clinical investigation and evaluation
- Post-Market Surveillance (PMS)
- Quality Management System (QMS)
- Device traceability (UDI)
- Interoperability and Compatibility of connected devices
- Management of Software Of Unknown Provenance (SOUP)
- Cybersecurity, information security and data privacy
- Market access strategy and value demonstration to payers
- Applicability of Real World Data and Real World Evidence
We offer the following services to clarify the regulatory process and to ensure that your digital health innovations meet appropriate standards for Medical Device (MD) software development, validation, safety, performance, and data security.
Science-based, global product development strategy and planning
- Support the development of appropriate product positioning and claims
- Assist in innovative product qualification/classification and regulatory development plans
- Develop roadmaps towards international market approvals (EU, UK, US, Australasia, South America)
- Develop strategies and protocols for collection and analysis of clinical evidence required, including Real World Evidence where appropriate
- Advise on/conduct regulatory bodies strategic and product development meetings (Notified Bodies, EU Competent Authorities, US Food and Drug Administration)
- Support with selection of EU Notified Body and UK Approved Body
- Assist with risk analysis and risk management plan, including fulfilment of requirements for usability
- Support conformity with software development lifecycle requirements from planning and development to validation, maintenance and post market changes (e.g. IEC 62304, IEC 82304-1)
- Develop and submit regulatory files (EU CE and UKCA Technical Files, US 510(k), PMA and De Novo, Canada, Australasia, South America)
- Develop and/ or optimize Quality Management Systems, including vigilance
- Advise on labeling and advertising
Our services apply but are not limited to the following types of digital technologies:
- Mobile medical applications
- Software as Medical Device (SaMD)
- Wearable/Connected devices
- Digital/Artificial Intelligence
- Predictive/Diagnostic/Therapeutic algorithms
- Clinical Decision Support (CDS) software
- Virtual/Augmented reality
- Expert systems/Robotic systems
- Computer-Aided Diagnosis (CADe, CADx) / PACS