SGB QA/RA Consulting was launched in 2017 to provide a complete range of services to meet the QA/RA compliance needs of medical device companies. We have over 25 years’ experience working with a range of medical device clients from start-ups to global multi-nationals on a wide range of projects including: MDD to MDR Upgrade IVDD to IVDR Upgrade ISO 13485:2016 CE Marking Audit Remediation Market Access: 510k Submissions / MDSAP / ASEAN / Canada / Australia Brexit Preparation - EU Authorised Representative / UK Responsible Person Internal Auditing (ISO 13485, ISO 27001) FDA Warning Letters / Remediation Software as a Medical Device (SaMD) Digital Health & Cybersecurity UDI (Unique Device Identification) Outsourced Monthly QA/RA Support Bespoke Remote / Onsite Client Training