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We Understand Quality and Regulatory

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None of your engineers like documentation (does anybody?).  Let us help you with the process so that it is as painless as possible.  We have the experience to make it easy.

Quality Systems

We have set up and operated quality systems compliant to ISO13485, CMDCAS and 21 CFR 820.  We also have experience with risk analysis compliant to ISO 14971 and can help you prepare the documentation required for IEC 60601 (3rd edition) approval.

We have defended our work to multiple auditors (including the US FDA and Health Canada) so we are confident in what we do.

Verification and Validation

V&V can be very confusing to those not accustomed to the approach.  It requires a bit of a different mindset from what many engineers are used to.  We can help you here with everything from advising as to how to validate a piece of equipment or medical device to preparing the protocols and reports that are required.  The scope is up to you.

Regulatory Approvals

We have prepared Premarket Approval (PMA) documents for no fewer than 6 separate devices.  Each of these submissions were approved by the US FDA.

We haven’t forgotten Health Canada or Europe either.  We have two successful CE marks under our belt and have achieved multiple approvals from Health Canada both for facilities and for medical devices.

We have Developed Unique Medical Devices

 

The majority of our design work is covered by confidentiality provisions and we take those VERY seriously.  However everyone wants to see pictures from previous projects so here are a few that we CAN share.  You’ll forgive us if we don’t provide a lot of detail but below is a list of some of our past projects…

Disposable Products
    • Sterile disposable kit for urology
    • Sterile disposable kits for oncology
    • Specialized manufacturing process for medical fiber optics
Sustained Drug Delivery Systems
    • Sterile disposable kit for ophthalmology
    • Novel insertion tools for ease of placement
    • Specialized manufacturing process for “no flash” silicone molding
Capital Equipment for Light Delivery
    • Laser and LED-based capital equipment
    • Simplified medical laser design that resulted in a reduced manufacturing cost (by half) while simplifying operation
    • Development of new equipment while maintaining the performance metrics to link with clinical trial results already submitted and approved.