Class III Biomedical Design

Hydrix’s dedicated Class III medical device development group has deep portfolio experience and the know how to deliver high end, high risk projects  - covering both profound experience in technical design & delivery, and a deep understanding of the submission process and how to tell the story, across:

 

  • Clinical process
  • Regulatory process, requirements, guidance
  • State-of-the-art technology and design
  • Standards and differences between countries/regions
  • Architecture and delivery of an effective program of work by aligning the business strategy and goals with a solid regulatory and development strategy.


 

Class III


Class III devices are determined by their role in sustaining or supporting life, or present an unacceptable level of risk to the patient.


The process for development involves animal trials, pre-clinical and clinical trials prior to device submission. Device approval is gained by submitting design dossiers for Pre-Market Approval (PMA). This submission takes 180+ days and is a scientific review of all aspects of device development including clinical data, lab results, papers, design procedures and full design documentation.

 

 

Documentation to support the PMA submission (e.g. investigation outputs, lab results, etc) must be created under a process that is acceptable to regulatory bodies such as the FDA, e.g. GLP, GCP, GMP. Failure to do so will see this evidence being excluded and will require new testing to be carried out in accordance with the regulatory body’s requirements.

 

For Class III, checks for full compliance to the QSR (Quality System Regulations) form part of the submission. Without the supply of this documentation with the Class III submission, onsite audits and evidence of compliance will be requested and slow the submission process down.

 

Hydrix’s dedicated Class III development group understands these requirements throughout the research and development lifecycle to bring our clients the confidence that the documentation we create will meet the required regulations.

 

Hydrix works with our Clients to develop the necessary documentation across:

 

  • Research and lab based results
  • Design control procedures
  • Planning
  • Requirements management
  • Risk management
  • Verification
  • Design reviews
  • Project governance and oversight
  • Manufacturing


Moreover due to the risks of success for Class III devices getting approval, the device design process must be led by a group that speaks the language that transverses the regulations and standards, but also knows the differences between the regulatory bodies and their requirements. A successful submission is more about navigating the regulations and standards then it is about the design.

 

 

Hydrix’s understanding of the clinical pathway to prove safety and efficacy means we know:

 

  • What to deliver and when
  • Information required (format, type, by whom, when, etc)
  • An understanding of the submission process and how the architecture and design can impact a submission to the point where the device may never get approval

The engineering solution is not possible without the knowledge of how to apply the standards … and that only comes through the sort of experience the Hydrix has developed over many projects (and not just through reading the regulatory agency manuals).