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.
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
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...
ISO 13485 / 9001 Certified
SO Rx is fully certified to the highest standards of FDA requirements
Localized contracts and legal representation put in place to insure your IP is protected
Our project teams are multi-lingual, so you never have to worry about communication barriers
All your product improvements carefully documented and coordinated across all supply side vendors
We’ve been around since 2008 and have been producing medical devices for 3+ years
We understand all the stages of commercialization and have in place the relevant supply chain solutions to accommodate, from trials to mass production
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.
We understand the need for quality management systems at every stage of your product's lifecycle and our team is trained and certified in the globally recognised certifications required.
The tools and talent required to deliver a results driven, reliable and responsive supply chain and project management.
Quality and compliance is always at the top of our priorities. We create manufacturing solutions at the key intersection of engineering, manufacturing, product development and supply chain management.
