MedicalQMS Australia
MedicalQMS Australia is a leading provider of minimally invasive medical devices, dedicated to improving patient outcomes and supporting healthcare professionals worldwide. They offer a unique portfolio of innovative solutions across various clinical specialties.
MedicalQMS Australia, operating under the Cook Medical brand, is a significant player in the global medical technology landscape. Founded on the principle of invention and a commitment to improving lives, the company specializes in developing, manufacturing, and delivering a unique portfolio of minimally invasive medical devices. These devices are designed to provide healthcare professionals with the tools they need to enhance patient care and facilitate recovery. The company's history is rooted in innovation, starting as a home-based business in 1963 and evolving into a thriving global enterprise. MedicalQMS Australia serves nearly every area of the modern hospital, supporting approximately 60 clinical specialties. Their approach is customer-centric, emphasizing listening to healthcare professionals to identify unmet needs and developing innovative solutions through their Vascular and MedSurg clinical divisions. Driven by core values of quality, ethics, and service, MedicalQMS Australia is committed to advancing patient care. They operate with a strong sense of responsibility towards patients, customers, and communities, ensuring fair and honest partnerships. Their dedication to 'doing the right thing' underpins their operations and their continuous pursuit of excellence in the field of medical technology.
About
**Who they are**
MedicalQMS Australia is a provider of minimally invasive medical devices, dedicated to improving patient outcomes and supporting healthcare professionals. They offer innovative solutions across various clinical specialties.
**Expertise & scope**
* Quality Management System (QMS) Services and Audits
* Regulatory Affairs support
* QMS Setup and implementation for ISO 13485:2016 and 21CFR820
* Training for Regulatory Affairs and QMS, including ISO 13485, MDR, MDSAP, and internal auditor courses
* TGA Sponsor Representation for medical device companies in Australia
* CyberSecurity Testing for medical devices, following regulatory bodies, OWASP, CIS, and ISO security guidelines
* Assistance with regulatory and QMS documentation and advice
**Reputation / proof points**
* 20 years of experience in the medical device industry, including management of Quality, Regulatory Affairs, and auditing.
* Achieved 100% compliance for all clients.
MedicalQMS Australia is a provider of minimally invasive medical devices, dedicated to improving patient outcomes and supporting healthcare professionals. They offer innovative solutions across various clinical specialties.
**Expertise & scope**
* Quality Management System (QMS) Services and Audits
* Regulatory Affairs support
* QMS Setup and implementation for ISO 13485:2016 and 21CFR820
* Training for Regulatory Affairs and QMS, including ISO 13485, MDR, MDSAP, and internal auditor courses
* TGA Sponsor Representation for medical device companies in Australia
* CyberSecurity Testing for medical devices, following regulatory bodies, OWASP, CIS, and ISO security guidelines
* Assistance with regulatory and QMS documentation and advice
**Reputation / proof points**
* 20 years of experience in the medical device industry, including management of Quality, Regulatory Affairs, and auditing.
* Achieved 100% compliance for all clients.
Additional information
MedicalQMS Australia specializes in comprehensive support for medical device companies navigating complex regulatory landscapes. Their services are designed to ensure compliance and facilitate market access. They offer tailored QMS setup and training, crucial for achieving certifications like ISO 13485. For Australian market entry, their TGA Sponsor Representation is a key service. Additionally, their cybersecurity testing adheres to stringent industry standards, providing essential documentation for pre/post-market submissions. Buyers can expect a focus on getting compliance right from the outset.
Key Highlights
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Offers TGA Sponsor Representation for medical device companies.
Source
“Australian TGA Sponsor Representation for Medical Device Companies”
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Provides cybersecurity testing for medical devices, adhering to regulatory bodies, OWASP, CIS, and ISO security guidelines.
Source
“While testing, we follow regulatory bodies, OWASP, CIS and ISO security testing guidelines.”
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Has achieved 100% compliance for all clients.
Source
“We pride ourselves on having achieved 100% compliance for all our clients.”
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Possesses 20 years of experience in the medical device industry.
Source
“With 20 years’ experience in the medical device industry”
Certifications & Trust Signals
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Offers QMS Setup in compliance with ISO 13485:2016 and 21CFR820.
Source
“Medical Device Quality System Setup ISO 13485:2016 and 21CFR820”
Buyer Snapshot
Best for
- Medical device companies seeking TGA Sponsor Representation.
- Organizations needing QMS setup and regulatory affairs guidance.
- Firms requiring cybersecurity testing and documentation for medical devices.
How engagement typically works
- Consultative approach to regulatory and QMS needs.
- Focus on achieving 100% compliance.
- Provision of expert advice and documentation.
Typical deliverables
- Established Quality Management Systems.
- Regulatory affairs strategy and support.
- TGA Sponsor Representation services.
- Cybersecurity testing reports and documentation.
- ISO 13485 and other relevant training.
Good to know
- Best when engaging for specific regulatory or QMS needs within the Australian market.
HQ:
Brisbane, AU
Languages:
English
Timezones:
Australia/Sydney
Status:
listed
Services & Capabilities
AU TGA Sponsor Services
Jurisdictions:
AU
Countries:
AU
Industries:
Digital health, SaMD, Medical devices
Portfolio:
6-25
Onboarding time:
7–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
AUD 4,500
Included services:
Annual ARTG charge reminders and continuity planning, eBusiness Services account setup support, Sponsor address and labeling review, Conformity assessment evidence mapping (EU/UK/US/CA)
Evidence Review:
Yes
Australian Entity State:
Sponsor
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
Additional tga_sponsor_au Details
Supports Artg
Yes
Onboarding Steps
The website mentions the need for QMS setup and regulatory affairs requirements, implying a structured process for compliance and representation.
