SGB Consulting Services (Australia Market Access)
SGB Consulting Ltd
SGB Consulting Services offers expert regulatory affairs and quality assurance support for medical devices and IVDs. They specialize in global market access, TGA Australia compliance, and navigating complex regulations like MDR and IVDR.
SGB Consulting Services, operating as SGB QA/RA Consulting Ltd, is a specialized consultancy focused on global market access and regulatory compliance for medical devices and In Vitro Diagnostic (IVD) products. With extensive experience, they assist clients in navigating the stringent requirements of regulatory bodies worldwide, including the Therapeutic Goods Administration (TGA) in Australia. Their expertise covers the entire lifecycle of medical devices, from initial development and Quality Management System (QMS) implementation to achieving compliance with international standards such as ISO 13485:2016 and ISO 27001:2022. They are adept at preparing technical documentation, managing risk, and ensuring devices meet the necessary criteria for market entry. SGB Consulting Services provides tailored support for Software as a Medical Device (SaMD) and helps clients achieve compliance in key markets including the UK, EU, and USA. They also offer guidance on post-Brexit solutions and UDI/EUDAMED compliance, ensuring businesses can successfully bring their innovative healthcare technologies to global consumers.
About
**Who they are**
SGB Consulting Services (Australia Market Access) is a regulatory affairs and quality assurance consultancy specializing in global market access for medical devices and IVDs. They offer expert support in navigating complex regulatory landscapes.
**Expertise & scope**
* Expertise in TGA Australia compliance, including understanding classification, conformity assessment, and ARTG listing requirements.
* Support for MDR and IVDR transitions.
* Assistance with ISO 13485:2016 and ISO 27001:2022 standards.
* Services include Quality Management System (QMS) development, Technical File creation, and Risk Management documentation.
* Market access support for the United Kingdom, Europe, United States, Canada, Asia, Australia, and the Middle East.
* Specialization in UDI Compliance Solutions and Post-Brexit Solutions.
**Reputation / proof points**
* Over twenty-three years of experience in the Medical Devices & IVD sectors.
* Accredited as an Internationally Certified Principal Auditor.
* Successfully guided over 500 clients to ISO, FDA, Canadian, and CE compliance.
SGB Consulting Services (Australia Market Access) is a regulatory affairs and quality assurance consultancy specializing in global market access for medical devices and IVDs. They offer expert support in navigating complex regulatory landscapes.
**Expertise & scope**
* Expertise in TGA Australia compliance, including understanding classification, conformity assessment, and ARTG listing requirements.
* Support for MDR and IVDR transitions.
* Assistance with ISO 13485:2016 and ISO 27001:2022 standards.
* Services include Quality Management System (QMS) development, Technical File creation, and Risk Management documentation.
* Market access support for the United Kingdom, Europe, United States, Canada, Asia, Australia, and the Middle East.
* Specialization in UDI Compliance Solutions and Post-Brexit Solutions.
**Reputation / proof points**
* Over twenty-three years of experience in the Medical Devices & IVD sectors.
* Accredited as an Internationally Certified Principal Auditor.
* Successfully guided over 500 clients to ISO, FDA, Canadian, and CE compliance.
Additional information
SGB Consulting Services focuses on providing comprehensive regulatory support for medical devices and IVDs. Their services are designed to help manufacturers achieve and maintain compliance with international standards and regulatory bodies. Key deliverables often include the development of Quality Management Systems (QMS), Technical Files, and Risk Management documentation necessary for market entry. For Australian market access, they guide clients through the TGA's requirements, including device classification, conformity assessment, and ARTG listing. Engagement typically involves consultation to understand specific product needs and regulatory pathways.
Key Highlights
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Specializes in TGA Australia market access, guiding clients through classification, conformity assessment, and ARTG listing.
Source
“Accessing the Australian market for medical devices requires compliance with the regulatory requirements set forth by the Therapeutic Goods Administration (TGA).”
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Offers support for MDR and IVDR transitions.
Source
“MDR Transition”
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Provides assistance with ISO 13485:2016 and ISO 27001:2022 standards.
Source
“ISO 27001:2022”
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Has successfully guided over 500 clients to ISO, FDA, Canadian, and CE compliance.
Source
“With an impeccable record, I have successfully guided over 500 clients to ISO, FDA, Canadian and CE compliance with the development and improvement of Quality Management Systems (QMS) and Technical Files.”
Certifications & Trust Signals
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Over twenty-three years of experience in the Medical Devices & IVD sectors.
Source
“I'm a global Quality Assurance and Regulatory Affairs specialist with over twenty three years’ experience in the Medical Devices & IVD sectors.”
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Accredited as an Internationally Certified Principal Auditor.
Source
“Accredited as an Internationally Certified Principal Auditor, I have been instrumental in Quality Assurance and Regulatory Affairs strategy for large medical device / IVD manufacturers.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking TGA Australia market access.
- Companies needing assistance with MDR/IVDR transitions.
- Businesses requiring QMS and Technical File development.
How engagement typically works
- Consultative approach to understand client needs.
- Project-based support for specific regulatory milestones.
- Guidance on complex regulatory requirements.
Typical deliverables
- TGA compliance strategy and execution.
- ARTG listing support.
- Quality Management System (QMS) documentation.
- Technical File and Risk Management documentation.
- MDR/IVDR transition plans.
Good to know
- Best when clients require specialized expertise in medical device and IVD regulations.
- Suitable for companies targeting the Australian market.
HQ:
Bristol, United Kingdom
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Medical devices, Dental
Portfolio:
6-25
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Starting from:
AUD 6,000
Included services:
Sponsor address and labeling review, Change notification and variation assessment, Annual ARTG charge reminders and continuity planning, TGA device classification and grouping
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Additional tga_sponsor_au Details
Device Classes Supported
Classes I-IV
Supports Artg
Yes
Onboarding Steps
Key steps for Australian market access include determining device classification, undergoing conformity assessment, and applying for ARTG listing.
