Mission
We are committed to providing quality and regulatory-related consulting services to customers and enhancing their capability to comply with regulatory guidelines. We are committed to ensuring the best quality experience and optimizing organizational outcomes in terms of business and compliance.
Current challenges in the industry for QMS and Regulations
- Inconsistency Across Multiple QMS
- Lack of emphasis on Precision
- Quality is inconsistent
- Lack of Agility
- Impact on Business an Usage
- Problems in approvals requirement for tender floating – MD-QMS, ICMED, CE, FDA, MDSAP.
Our Key Strength
- Experience in implementing the QMS scaled across business units including all the functions
- Holds experienced Auditors and SMEs related to QMS and Regulations
- Save maintenance and enhancement efforts by maintaining QMS periodically and providing training
- Increased participation and business through various approvals and certifications
- Expertise in all domains of Medical Devices
Our Services
QMS documentation and certification with the help of third-party certification agencies
Customized Training on regulatory topics (ISO 14971, ISO 13485, IMDR, MDSAP, EU-MDR, and US-FDA, CDSCO etc)
Tailored product-specific templates for product regulatory compliance and approvals like CDSCO and EU MDR
Expert review/ Gap assessment of the documents as per regulatory & and standard requirements
Onsite internal audits for QMS and Regulatory compliances
Testing of the devices from third-party approved labs
Benefits
High-quality user experience
Collaborations and Communications for continual improvements of the system and Business
Increased Agility within the system
Less Human errors and effort overrun
High efficiency in terms of practical operations
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