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
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- 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
Ispe Australasia Affiliate,
Laseraid Anz,
Cannaponics Ltd,
Medilaze Surgical,
Department Of Medical Devices, Niper Hyderabad,
Hangzhou Alltest Biotech Co.,ltd.,
Adjutor Healthcare Group,
Nxstage Home Hemodialysis,
Medicmall,
Fields Contracting Engineers.
Eleven Borders Pty Ltd's categories are Medical Equipment Manufacturing
Eleven Borders Pty Ltd's founding year is 2022
