About us

We are a fully remote company founded by a team of certified ISO Lead Auditors dedicated to support software companies that wish to bring their innovative products to the Health Tech Market quickly. Our services include:

• Assessments of current practices, identify areas for improvement and help streamline processes making it straightforward to handle audits, assessments and compliance with the applicable regulations.
• Assessments of the product against MDR classification criteria and prepare a preliminary classification report.
• Evaluation of the adherence to regulatory requirements, identifying areas of improvement, and implementing effective strategies to ensure compliance.
• Support during notified body audits or guidance in auditing subcontractors.
• Assistance with the development of Standard Operating Procedures (SOPs) for critical processes within the QMS.
• Ad-hoc support: on-demand consulting support for specific regulatory inquiries or challenges that arise during the implementation of compliance strategies.
• Conduct training sessions for relevant staff on the new QMS and SOPs to ensure understanding and compliance.
• Schedule regular reviews and updates to the QMS based on feedback and performance metrics.