Eleven Borders Pty
Medical Equipment Manufacturing • 
Melbourne, Victoria, Australia • 1-10 Employees
Company overview
| Headquarters | Melbourne, Victoria, Australia |
| Website | |
| NAICS | 3391 |
| Keywords | Clinical Research Services, Quality Management Systems, Gap Assessments, Eu Mdr 2017/745 Applications, Iso13485 | 21 Cfr820 Implementation, Internal Audits | Supplier Audits, Medtech Regulatory Services, Regulatory & Clinical Strategy, Tga Conformity Assessment Applications |
| Founded | 2022 |
| Employees | 1-10 |
Key Contact at Eleven Borders Pty
Paul Clark
Founder | Director
Eleven Borders Pty Email Formats
Eleven Borders Pty uses 2 email formats. The most common is {first initial}{last name} (e.g., jdoe@elevenborders.com), used 50% of the time.
| Format | Example | Percentage |
|---|---|---|
{first initial}{last name} | jdoe@elevenborders.com | 50% |
{first name}{last name} | johndoe@elevenborders.com | 50% |
About Eleven Borders Pty
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.
Eleven Borders Pty revenue & valuation
| Annual revenue | $256,665 |
| Revenue per employee | $86,000 |
| Estimated valuation?This valuation is estimated based on industry average for the Medical Equipment Manufacturing industry and current estimated revenues | $821,328 |
| Total funding | No funding |
Employees by Management Level
Total employees: 1-10
Seniority
Employees
Employees by Department
Eleven Borders Pty has 1 employees across 1 departments.
Departments
Number of employees
Funding Data
Eleven Borders Pty has never raised funding before.
Eleven Borders Pty Tech Stack
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Miscellaneous
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Slovenia
United Kingdom
United States
Germany
Netherlands
Frequently asked questions
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