SO | RX

SO Rx provides Supply Chain Management services for medical technology devices

Our Asia based network of FDA approved vendors and suppliers allow you to ramp-up your product commercialization efforts, insuring competitive cost of goods, while meeting all FDA and CE class regulatory requirements.

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Get regulatory headaches off your books.

  • Quality management, traceability, and production validation

  • Design History maintenance and validation

  • Engineering and production support throughout your project

  • Management of regulatory compliance and audits

  • ISO 13485 certified

  • FDA / CE Medical

 
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QMS. Qualified Overseas Vendors. CAPA. IP Protection.

Navigating the waters for medical device startups is what we do.

You’ve worked hard to prove your concept, raise capital, and conduct R&D. Now you need to have your product line manufactured at excellent quality, for a market beating price, while complying with the heavy regulatory burden that comes with the territory...

 

...this is where we come in.


 

What we offer

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  • ISO 13485 / 9001 Certified

SO Rx is fully certified to the highest standards of FDA requirements 

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  • Rock solid IP protection

Localized contracts and legal representation put in place to insure your IP is protected

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  • QMS Management & Traceability

Our project teams are multi-lingual, so you never have to worry about communication barriers

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  • Design History Files

All your product improvements carefully documented and coordinated across all supply side vendors 

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  • Multi Discipline Expertise

We’ve been around since 2008 and have been producing medical devices for 3+ years

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  • Future Flexible

We understand all the stages of commercialization and have in place the relevant supply chain solutions to accommodate, from trials to mass production

 
 

About Us

SO Rx is an Asia based contract manufacturing and commercialization consultancy. With a team of production and quality managers, R&D specialists, and regulatory experts, we provide our clients with a fully integrated production and quality solution. Based in Taipei, Taiwan, we've been at the forefront of manufacturing innovative consumer technology for more than 10 years. For the last 3+ years we have successfully produced qualified medical devices and continue to deliver commercial solutions for our clients with our nimble product development capabilities, on the ground project management, and fully certified manufacturing. 

 
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Ready to reliably outsource your med device manufacturing?

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