|Minimum Order Quantity||2 Set|
|Usage/Application||for pharma companies|
|Certification||Renewal, New Certification|
|Industry||Any, Drug, Chemical, Food, Manufacturing|
|Minimum Order Quantity||2 Unit|
|Certification||New Certification, Renewal|
|Minimum Order Quantity||1 Unit|
|Type of Industry / Business||Medical Device Industries|
Now a day for the market need, medical device companies pursuing commercialization to a global regulatory strategy. We offer strategic guidance and support at every stage of the product manufacturing and development process.
Our regulatory experts have specialized knowledge of the many regulatory jurisdictions, including Indian and foreign country regulation. Our support ranges widely, including Layout preparation, Layout submission to local authorities, CE marking, ISO 13485, ISO 15378, US FDA medical device classification, pre-approval inspections and FDA District Office meetings.
How We Work
OPERON provides regulatory support in multiple ways:
· provide consultation and advice as standard regulation
· Functioning as a virtual regulatory and QA department to meet Regulatory Norms.
· Providing emergency response teams for query resolution by conference calling, recall handling or audit responses
Through the years, we’ve supported hundreds of clients seeking regulatory designations, approvals, and international registrations. Our other services include:
· Device classification as per Rules
· Guidance for equipment procurement
· Import and export requirements
· Labeling and advertising review
· FDA meetings
· Real-time reviews
· International registrations and submissions
· Device listing and establishment registration
· Creation of technical files
· Post-market support
· Recall planning and management
· Medical device reporting and complaint handling
· Inspection advice and management
· Quality Systems training — individual or small group, management or production
· Perform due diligence assessments
· Audit preparation, training for perusal.
· Preparing and developing SOPs
· Online training to maintains the system update.