Many strategic decisions are involved in launching a new medical device, entering a new market and in ensuring that your product/operations continuously meet regulatory requirements. Making the right decisions requires a deep understanding of the requirements contained in the applicable regulations and standards.
Symbioteq has extensive experience working with regulatory and market access in the EU, US, Canada, Australia, Japan, China, Brazil, India, the UAE, and other countries. We help companies succeed in their regulatory work and make the right decisions at the right time. No matter what market you want to launch your products in, we can support you with interpretation and effective implementation.
Often, we start with a regulatory analysis which we use as the basis for the intended use, and to evaluate the product classification and requirements to be met for a given market. Based on the analysis and evaluation of your current situation in the technical documentation, quality management system and maturity, we can introduce a regulatory strategy that involves an effective and safe launch of your medical device products in new markets. We can present a training plan and even be responsible for the training.
Ongoing support — Qualified Person
Symbioteq can give you guidance on everything from specific questions to continuous support in your ongoing business operations. Symbioteq can also manage your contacts with the authorities (the FDA, the Swedish Läkemedelsverket and others) as well as with a Notified Body (NB).
Symbioteq is your partner for all matters relating to MDD, AIMD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 60601, EN 62366, IEC 62304, ISO 10993, QSR (FDA 21 CFR Part 820), and other regulations and standards in medical device industry.