We offer medical device product development consulting services to assist clients with any product development challenge.
We can provide customers with market research services for designated products and provide product research reports, including product market size, competitive brands and competitive product analysis, target customer analysis, products’ medical insurance status, clinical use feedback, etc. The content of the report can be customized according to customer needs.
We assist our client in planning product registration strategy by distinguishing potential regulatory challenges and difficulties, and finding suitable paths to fast-track product commercialization, along with identifying estimated costs and timelines for all pivotal activities. We offer the following services:
1. Registration strategy analysis / Estimation of pre-registration costs and time
2. Registration execution strategy / Registration path risk assessment
Depending on our clients' needs, we offer a wide range of customized consulting services, including but not limited to the following:
1) Regulatory Consultation
1. Medical device industry polices, updates and interpretation.
2. Global market access policies, updates and interpretation
2) Professional Training
1. Regulatory training
2. Quality management system training
3. Clinical trial management training
4. Other company-specific training
3) Medical Device Translation Services
Our medical device translation team focuses on professional translation in the medical device industry, covering pre-market regulatory process, product testing, expert panel meeting, post-market surveillance, adverse events and other professional technical dossier translation, as well as simultaneous translation and conference interpretation services for various international medical device conferences. Our translation languages include English, Chinese, Japanese, German, French and other languages.