Cutting edge medical equipment should be available everywhere.  The team of experts at Borderless MedDev have experience bringing new technologies to markets across the globe including the USA, the European Union, the United Kingdom, Canada, and Australia but also pride ourselves in being able to make sure that those products also reach the rest of the world as well.  Examples of our services:

​

FDA Regulatory Clearances

• Regulatory Strategic Planning

• Organizing Pre-Submission Meetings

• Breakthrough Device Program Applications

• 510(k) Submissions

• De Novo Submissions

• 3rd Party 510(k) Submissions

• 510(k) Remediation

• Post Market Issues:  Complaints and Recalls

• Statistical Analyses

• GUDID Management

​​

ISO 13485/FDA Quality System Requirements (QSR)/MDSAP

• Process Development

• Training

• Internal Audits

• Supplier Audits

• Design Controls/ Design History Files

  • Risk Management

  • Usability

  • Labelling

  • EMC

  • Safety

  • Software documentation

  • Wireless registrations and testing expertise

  • Cyber Security

  • Coexistence

  • Interoperability

  • Biocompatibility

  • Mechanical Testing​

• Technical Files​

​​

International Regulatory Compliance

• Health Canada

• European Medical Device Regulations (MDR) and GDPR

• Australian Therapeutic Goods Administration (TGA)