SGB QA/RA Consulting Ltd

medical devices

About

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

Technologies

Outlook Google Font API Apache Mobile Friendly Google Tag Manager Circle

Keywords

medical equipment manufacturing technical file development regulatory compliance udi compliance medical device cybersecurity risk management fda approval support regulatory strategy development eudamed project management market access services regulatory advice ukca marking regulatory project management regulatory gap analysis healthcare notified body liaison regulatory pathway optimization regulatory compliance for telemedicine apps risk management device reclassification support manufacturing uk responsible person services post brexit solutions ivdr compliance device lifecycle management auditing and certification device classification support device registration notified body support regulatory training samd regulatory support

Location

High Street, Bristol, England, United Kingdom, BS36 1

Related Companies

Companies in the same industry