Consultants for Medical Device, Software in a Medical Device and SaMD development

With many years of experience within design, development, validation, CE and FDA approval with focus on medical devices, apps and server solutions for software as a medical device (SaMD), we offer the following expertise in:

Expertises

Compliance

• Medical devices regulatory compliance (MDR)
• In vitro devices regulatory compliance (IVDR)

Software development for the medical businesses

• Software for medical devices (62304)
• Software as a medical device (SAMD)

Project and Product Management

• Prince2
• Project Management
• Professional SCRUM Master
• Professional SCRUM Product Owner

Design control

• Construction and maintenance of QMS (13485)
• Requirements Engineering
• Architectural design
• Usability engineering (62366)
• Verification and Validation
• Reporting

Risk Management

• Product Risk Management (14971 & 24971)
• Software Risk Management
• Cybersecurity Risk Management
• CAPA procedures
• Post Market Surveillance (20416)

Cybersecurity

• Cybersecurity for companies (27001)
• Cybersecurity for products
• Industrial cybersecurity (62443)

Medical device certification

• Technical file for CE marking
• FDA 510(k) submission

Auditing

• Internal Auditor
• External Auditor

Directives and regulation

• EU regulations: Medical device regulation 2017/745
• EU regulations: In vitro diagnostic medical devices 2017/746
• FDA regulations: CFR 21 Part 820, Part 11
• EU Directive: Medical Device Directive MDD 93/42/E
• EU Directive: In vitro diagnostic directive IVDD 98/79/EC, AIMDD 90/385

Standards

The Following standards are in focus:

• ISO 13485 – Medical devices – Quality Management Systems
• ISO 14971, ISO 24971 – Medical devices – Risk management
• IEC 62304 – Software for medical devices
• IEC 82304 – Medical device software and SAMD
• IEC 62366 – Usability engineering
• ISO/TR 20416 – Post Market Surveillance
• ISO 27001 – Information security, cybersecurity
• IEC 62443 – Industrial cybersecurity
• IEC 81001-5-1 – Health software and health IT systems safety
• ISO 15223-1 – Labelling of medical devices
• AAMI TIR57 – Principles for medical device security – Risk management
• AAMI TIR97 – Principles for medical device security – Postmarket risk management for device manufacturers
• AAMI TIR45 – Guidance on the use of agile practices in the development of medical device software

Contact Information

For help with medical device compliance, email us at info@scengineering.dk or use the contact form.