Regulatory strategy for SaMD and healthcare software
Implementing, maintaining and improving business management systems
UK, EU and US medical device regulatory clearance
Technical planning and implementation
Labelling and user documentation
Supporting regulatory roles
Consultation on regulatory pathways and finding routes to market, as well as helping to create strategies for growth and adoption of quality, privacy and security processes as businesses adapt and expand.
Consultation and assistance in the implementation of policies and processes, staff training and internal auditing activities across quality, security, privacy and business continuity management systems.
Assistance planning software medical device design, clinical evaluation and filing activities as well as offering support in creating design documentation and regulatory filings.
Helping to plan technical solutions to quality management and software production problems and providing technical support in commissioning, integrating and customising systems such as Atlassian Confluence and Jira, the Google suite, Microsoft 365, and other off the shelf eQMS and design tools.
Help with the DSPT, DCB0129 and DTAC standards required to work with NHS Trusts.
Advice on product labelling and instructions for use, providing regulatory review of labelling and writing user documentation if needed.
UK Responsible Person services, acting as PRRC where required, to a Manufacturer or Authorised Representative, as well as handling registration with and reporting to regulators.