Welcome to MDRA Solutions Inc.
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The constant push for new and higher level regulations worldwide in the Medical Device Industry is creating many regulatory challenges. Each Medical Device company must meet the regulatory requirements for the specific country in order to sell a device in that market. The purpose of these requirements is to demonstrate that the products are safe and effective. However, many medical device companies lack sufficient regulatory professionals needed to maintain compliance.
MDRA Solutions has a high level of expertise in the EU and international markets. We offer services worldwide at reasonable rates to help companies ensure compliance for their medical devices. |
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HOW CAN WE HELP?
International Regulatory Services
- Global markets (e.g. LATAM, APAC, ASEAN, and EMEA) project coordination and management
- China registration dossier and product technical requirements (PTR) preparation
- Prepare submissions for Class I, II and III first-time registrations, license renewals, change notifications
- Regulatory strategy in the global markets
EU Medical Device Regulations (MDR)
- EU technical file or design dossier remediation
- Summary Technical Documentation (STED) development and maintenance
- Labelling and IFU review
- Gap assessments
Regulatory Project Management
- Change request project management
- Lead and support hands-on projects in regulatory affairs
- Continuous improvement project strategies
Regulatory Intelligence
- Develop worldwide regulatory intelligence information for any platform
- Provide research and assessment of Medical Device/IVD regulations and standards
- Creative strategies on implementation of new solutions
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