US market access faster - no jargon filled pages laced with flow charts!

Every manufacturer, regardless of risk classification, must implement
a QSR compliant quality system. A quality management system provides
a structured and disciplined series of key processes to ensure a
company consistently complies with requirements during its day to day
operations. In this instance - to reliably manufacture and put into
US distribution a product that has received USFDA market access. Put
simply, each and every product you manufacture is virtually identical
to the one you the FDA granted market access to through your 510k
submission.

Every major jurisdiction requires a quality system as part of their
market access approval process and outlines specific requirements the
quality system must incorporate. No, you do not need a quality system
for each jurisdiction, as long as the system you have in place
accommodates their unique requirements.

Horizon Phoenix experts help you implement a manageable quality system
with several very important objectives:

1. Compliance to USFDA Quality System Regulation
2. Add value to your operations
3. Cultivate customer loyalty
4. Continually improve your product
5. Minimize the costs you incur and most importantly,
6. Integrate EU CE Mark and/or Health Canada CMDCAS quality system
requirements

One quality management system equals worldwide acceptance. Ask us how!

For more information on USFDA QSR and download a free copy of the
regulation click here.

Use Horizon Phoenix expertise and hard lessons we have learned from thousands of interactions with clients and regulatory authorities to get your systems and processes right the first time. There is no feeling like finishing your R&D, process implementation, quality system development and regulatory application and knowing you don't have to change a thing.

Ask Us How!...

Why Horizon Phoenix?

One system, one set of documentation for world-wide approval and market access.