Other Services
SGB Consulting Services has a proud history of meeting the QA/RA compliance needs of medical device companies.
We continue to support 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
✓ ISO 27001:2022
✓ CE Marking
✓ UK CA Marking
✓ Audit Remediation (QMS and Technical Documentation)
✓ Market Access: 510k Submissions / MDSAP / ASEAN / Canada / Australia
✓ Post Brexit Representation - 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
Call to discuss our full range of Medical Device services
CE Marking
Quality Management System (QMS), Technical File and Risk Management Documentation for the CE Mark.
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MDR Transition
We will help you ensure your medical devices remain compliant and able to be sold in the EU.
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IVDR Transition
We will help you ensure your IVDs remain compliant and able to be sold within the EU.
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ISO 27001:2022
SGB Consulting help you through the audit process to gain ISO 27001:2022 certification.
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ISO 13485:2016
Allow us to professionally lead you through the audit process to a successful ISO 13485:2016 certification.
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Software QA
We supply Software Quality Assurance and Regulatory Advice to ensure CE Mark or FDA approval.
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Market Access
Helping your company gain access and compliance in all the main markets for medical devices globally.
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Post Brexit Solutions
We support foreign device manufacturers to fully comply with the post-Brexit requirements.
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EUDAMED
informed about the latest updates and requirements regarding EUDAMED to ensure compliance.
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Other Services
As a one-stop-shop for our customers, our services cover everything required for continued compliance.
Read moreGlobal Market Access & Compliance
We can help you gain access to a wide range of global medical device markets including, but not limited to the following:
