Expert Regulatory and Technical advice
to Secure your Compliance

 

CE Marking and Technical File Preparation  –  FDA 510(k) and PMA submissions
Quality Systems – ISO and EN Standards – Risk Assessments 
Biocompatibility Testing – Sterilisation – Software validation – Electrical Safety
Clinical Trials  – Reimbursement

 

Brandwood Biomedical provides complete product life cycle  services  to medical device and diagnostics companies - supporting design, development and testing activities, risk analysis, quality systems implementation, technical file preparation and regulatory submissions.

We can help you to:

  • Conduct technical due diligence or prepare for investment readiness
  • develop the right technical and regulatory strategy for your business;
  • conduct ISO 14971 risk assessment
  • achieve appropriate solutions for preclinical and clinical product testing including compliance to ISO 10993, IEC 60601 electrical safety and specific product standards.
  • develop and implement ISO 13485 and FDA 21 CFR820 (QSR) quality systems
  • prepare regulatory submissions for Australia, US FDA, Europe and other jurisdictions including China
  • develop your skills through training and short courses in regulatory affairs and medical device development.


Services tailored to you

We can provide technical and regulatory support to match your stage of development and budget – including:

  • initial strategic assessments of regulatory pathways
  • project based activities such as risk assessments, management of device or materials testing or preparation of specific regulatory submissions
  • quality systems development and internal audit
  • technical file development and maintenance
  • continuing technical and regulatory support and guidance on postmarket systems

Q-Pulse®

Brandwood Biomedical is the Australian accredited supplier to the Life Sciences sector of Q-Pulse by Gael software.

Q-Pulse is a cost-effective, scalable and easy to use system that covers key quality and regulatory functions, allowing your organisation to advance through enhanced compliance management.  It is fully compliant with US FDA 21 CFR Part 11 requirements.  Our team has extensive hands-on knowledge in the implementation, training and use of this software.  Call us to talk about how we can configure an implementation that is right for you.

For more information please view this brochure, or contact us.