Regulatory

Comprehensive regulatory services for the global medical device industry.

At Eleven Borders, our regulatory knowledge spans over 30 years within the international Medical Device (MedTech) industry, with experience working directly within the medical device industry as well as various regulatory agencies. 

We have vast experience obtaining regulatory approvals in all the major global markets, covering a broad range of medical device technologies, including implantable devices, cardiovascular, ophthalmic, drug delivery, renal, gastrointestinal, surgical, intensive care, wound care, imaging, mental health, monitoring devices, Software as a Medical Device (SaMD), wearable technologies and other digital health technology.

We understand how regulatory agencies think and operate given our experience working within the walls of various regulatory agencies including the Therapeutic Goods Administration (TGA), EU Notified Bodies (TUV Product Services) and the Canadian Medical Devices Bureau, as well as our extensive firsthand experience liaising with the US Food and Drug Administration (FDA). Our clients range from multinational medical device companies to startup MedTech ventures in Australia, the US, the EU and Asia.

We have the capabilities to offer a full range of global regulatory services, including:

• Regulatory assessments of all medical device technologies
• Developing regulatory strategies and implementation plans for all key markets
• TGA conformity assessment applications and ARTG product registration
• FDA compliance assessment & gap analysis
• FDA resubmission ‘Q-Sub’ applications & meetings
• FDA 510k, De Novo and PMA submissions
• EU conformity assessment applications according to the EU MDR 2017/745
• Development of technical files according to the Australian Regulations and MDR 2017/745
• Canadian medical device licence applications
• Clinical evaluation plans and reports
• Post market surveillance, medical device vigilance and incident reporting
• Product recall and advisory notice management
• Software validation
• Sterilisation validation according to ISO 11135 & ISO 11137.