Medical Device Regulatory & Compliance

 

Safety for Medical Devices...

As the complexity of traditional medical devices exponentially expands capabilities and evolution, the need for ensuring stringent adherence to the all regulations are critical.  Especially when lives will be dependent on the use of medical devices.  Rubix LS has a well developed competence in regulatory affairs among 22 different countries.  Our team of experts have prior experience in the whole life-cycle within the industry.

 
 
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Planning, design control, validation, Maturity and regulatory product filings

The most critical portion of the medical device development life-cycle is the early stage.  With some of the changing requirements from the regulatory agencies, it can be difficult to understand at an early stage what you can be missing.  

The team at Rubix LS has developed a proprietary early submission check program to ascertain changes real-time and significant gaps within the filing package.  This significantly reduces review lead-time from regulatory agencies so you can continue to focus on what's important.  Innovation.  We know the design control process intimately and can help you through the registration process by:

  1. Traditional submission (PMA, 510k, IDE)
  2. Abbreviated submission (PMA, 510k)
  3. Special submission (PMA, 510k)
 
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Manufacturing & Continuing control

At the middle process of the complete medical device life-cycle, zero-defect manufacturing is important to maintain so end client and patients will be confident on a working device every time.  We integrate industry and global best practices to ensure that your manufacturing operation remains at a  zero-defect rate.

 
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post market surveillance & Support

At the tail end of the medical device life-cycle, after-care and market device monitoring, is one of the strong indicators on how your device is competing in the marketplace today.  With pressing and increased demands from regulatory agencies, on ensuring you control post-market surveillance actions, we will inject ourselves as an extension of your team to execute control mechanisms based on industry standards.  

We not only become an extension of your team, we increase the basis of a standard so that yours operation can be viewed as the next best practice for post market surveillance.