Company profile
Eleven Borders Pty Ltd
Medtech Regulatory, Quality & Clinical Consulting Company.
- Industry
- Medical Equipment Manufacturing
- Employees
- 3
- Headquarters
- Melbourne, VIC
- Founded
- 2022
- LinkedIn followers
- 99
- Office locations
- 1
Eleven Borders Pty Ltd company summary
Eleven Borders Pty Ltd is a company in the Medical Equipment Manufacturing industry, headquartered in Melbourne, VIC, founded in 2022. On LinkedIn the company has around 3 employees and 99 followers. Its listed specialties include Medtech Regulatory Services, Quality Management Systems, Clinical Research Services, ISO13485 | 21 CFR820 Implementation, Regulatory & Clinical Strategy.
What technology does Eleven Borders Pty Ltd use?
No technologies detected yet. Warmrank rechecks company websites on a rolling basis.
About Eleven Borders Pty Ltd
At Eleven Borders, we are dedicated to helping start-ups and medium-sized businesses navigate the complicated regulatory requirements and barriers of the MedTech industry, adopting global strategies and solutions to comply with international regulatory requirements. In addition to our experience in the industry, we provide an established international network, strong leadership, and a team-oriented approach to medical device regulation, focusing on the implementation of processes to ensure the long-term success of our clients. Our services include regulatory, clinical, and quality assessments, strategies and planning, implementation of quality management systems (QMS) according to ISO 13485/21 CFR 820, internal and external auditing, conformity assessment to the Australian Medical Device Regulations and the EU Medical Device Directive 2017/745, technical files and dossiers, FDA consulting including pre-submissions (Q-Subs), 513(g), 510(k), De Novo and PMA submissions, and breakthrough device designation; clinical research strategies and planning, clinical study reports and clinical evaluation reports (CERs), and vigilance and post-market surveillance.
Specialties
Where is Eleven Borders Pty Ltd located?
Eleven Borders Pty Ltd lists 1 location.
Compare companies similar to Eleven Borders Pty Ltd
More companies in Medical Equipment Manufacturing.
| Company | Industry | Employees | Founded | Headquarters |
|---|---|---|---|---|
Eleven Borders Pty Ltd elevenborders.com | Medical Equipment Manufacturing | 3 | 2022 | Melbourne, VIC |
 Boston Scientific bostonscientific.com | Medical Equipment Manufacturing | 54,970 | - | Marlborough, MA |
 BD bd.com | Medical Equipment Manufacturing | 46,224 | - | Franklin Lakes, New Jersey |
 Baxter International Inc. baxter.com | Medical Equipment Manufacturing | 39,218 | - | Deerfield, Illinois |
 Alcon alcon.com | Medical Equipment Manufacturing | 27,667 | - | Geneva, Switzerland |
 Smith+Nephew smith-nephew.com | Medical Equipment Manufacturing | 19,271 | - | Watford, Hertfordshire, GB |
 Zimmer Biomet EMEA zimmerbiomet.com | Medical Equipment Manufacturing | 19,125 | - | Warsaw, Indiana |
 Olympus Corporation olympus-global.com | Medical Equipment Manufacturing | 13,703 | 1919 | Shinjuku-ku, Tokyo |
 Intuitive intuitive.com | Medical Equipment Manufacturing | 13,091 | 1995 | California, 94086 |
 Medline Australia medline.com | Medical Equipment Manufacturing | 18,899 | - | Northfield, IL |
 Edwards Lifesciences edwards.com | Medical Equipment Manufacturing | 14,197 | 1958 | Irvine, CA |
Frequently asked questions about Eleven Borders Pty Ltd
What does Eleven Borders Pty Ltd do?
At Eleven Borders, we are dedicated to helping start-ups and medium-sized businesses navigate the complicated regulatory requirements and barriers of the MedTech industry, adopting global strategies and solutions to comply with international regulatory requirements. In addition to our experience in the industry, we provide an established international network, strong leadership, and a team-oriented approach to medical device regulation, focusing on the implementation of processes to ensure the long-term success of our clients. Our services include regulatory, clinical, and quality assessments, strategies and planning, implementation of quality management systems (QMS) according to ISO 13485/21 CFR 820, internal and external auditing, conformity assessment to the Australian Medical Device Regulations and the EU Medical Device Directive 2017/745, technical files and dossiers, FDA consulting including pre-submissions (Q-Subs), 513(g), 510(k), De Novo and PMA submissions, and breakthrough device designation; clinical research strategies and planning, clinical study reports and clinical evaluation reports (CERs), and vigilance and post-market surveillance.
How many employees does Eleven Borders Pty Ltd have?
Eleven Borders Pty Ltd has around 3 employees on LinkedIn.
Where is Eleven Borders Pty Ltd headquartered?
Eleven Borders Pty Ltd is headquartered in Melbourne, VIC.
When was Eleven Borders Pty Ltd founded?
Eleven Borders Pty Ltd was founded in 2022.
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