Verified email-pattern data for Eleven Borders Pty Ltd is currently limited. You can still use the company insights and contact sections below.
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.
Company Details
- Employees
- 3
- Founded
- -
- Address
- Melbourne, Vic 3184, Au
- Industry
- Medical Equipment Manufacturing
- Website
- http://www.elevenborders.com
- Keywords
- Medtech Regulatory Services, Quality Management Systems, Clinical Research Services, ISO13485 | 21 CFR820 Implementation, Regulatory & Clinical Strategy, Gap Assessments, FDA Pre-submissions| 510(k) | De Novo | PMA Filings, TGA Conformity Assessment Applications, EU MDR 2017/745 applications, Internal Audits | Supplier Audits.
- HQ
- Melbourne, VIC
Eleven Borders Pty Ltd Questions
Eleven Borders Pty Ltd's website is http://www.elevenborders.com
Eleven Borders Pty Ltd's LinkedIn profile is https://au.linkedin.com/company/eleven-borders-pty-ltd
Eleven Borders Pty Ltd has
3 employees.
View email and phone details for 3
employees at Eleven Borders Pty Ltd.
Eleven Borders Pty Ltd's industry is
Medical Equipment Manufacturing
Eleven Borders Pty Ltd's top competitors are
Nxstage Home Hemodialysis,
Medicmall,
Adjutor Healthcare Group,
Department Of Medical Devices, Niper Hyderabad,
Medilaze Surgical,
Hangzhou Alltest Biotech Co.,ltd.,
Cannaponics Ltd,
Ispe Australasia Affiliate,
Laseraid Anz,
Fields Contracting Engineers.
Eleven Borders Pty Ltd's categories are Medical Equipment Manufacturing
Eleven Borders Pty Ltd's founding year is 2022
Explore related pages
Related company profiles:
Top Eleven Borders Pty Ltd Employees
-
-
Caroline Clark
Quality Coordinator At Eleven Borders
Melbourne, Victoria, Australia, Australia
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Aero Online
Your AI prospecting assistant
Select data to include:
Total price:
$0.00
0 records × $0.02 per record
How It Works
Get a Free Account
Sign up for a free account. No credit card required. Up to 10 free credits.
Search the #1 Contact Database
Get contact details of over 750M+ profiles across 60M companies – all with industry-leading accuracy. Sales Navigator and Recruiter users, try out our Email Finder Extension.
Use our AI-Powered Email Finder
Find business and personal emails and mobile phone numbers with exclusive coverage across niche job titles, industries, and more for unparalleled targeting. Also available via our Contact Data API.