Here's the recent articles submitted by pooja pandit
Articles By pooja pandit
Top 10 Guideline For Quality Control In Medical Device Assembly
Submitted as: Cloud Catcher
Operon Strategist is the leading medical device regulatory consultant in India(read
entire article)
View : 52 Times
Category : General
Iv Cannula Manufacturing
Submitted as: Cloud Catcher
Trust Operon Strategist for expert IV cannula manufacturing guidance. With 12+ years of experience, we streamline your process from plant design to regulatory compliance. Our global Turnkey Project Solutions ensure success in 32 countries. Contact us to start your manufacturing journey with confidence.(read
entire article)
View : 48 Times
Category : Business
European Ce Mark Medical Device (eu Mdr) Consultant
Submitted as: Cloud catcher
The CE mark for medical devices confirms compliance with essential regulations for entry into European countries.
Operon Strategist, a leading EU MDR consultant, boasts a substantial presence throughout the EU, extending our support to countless medical device manufacturers to ensure CE compliance for Europe.(read
entire article)
View : 53 Times
Category : Business
A Guide To Surgical Suture Manufacturing
Submitted as: Cloud catcher
Paying close attention to detail and tight quality control procedures are essential when manufacturing surgical sutures. Surgeons choose the best suture materials for tissue approximation to maximize wound healing and scar aesthetics. The choice of sutures and needles varies widely across surgeons, and awareness of the numerous possibilities available enables doctors to form their preferences.(read
entire article)
View : 40 Times
Category : Business
From Design To Approval: The Journey Of Breathing Apparatus Manufacturing
Submitted as: Cloud catcher
Breathing apparatuses play a crucial role in various industries, ensuring respiratory protection for workers in hazardous environments and supporting medical interventions. Manufacturing these devices requires adherence to strict regulatory standards to guarantee their safety, efficacy, and reliability. In this blog post, we explore the manufacturing process of breathing apparatuses and delve into the regulatory compliance landscape that governs their production.(read
entire article)
View : 38 Times
Category : Business
8 Important Steps To Achieving Medical Device Approval
Submitted as: Cloud catcher
An Overview:
Introducing a new and innovative medical device to the market has the potential to significantly enhance the health and well-being of millions. However, before your device can make its mark, it must successfully navigate the intricate regulatory approval processes in the European Union (EU), the U.S., and other major jurisdictions worldwide. For first-time applicants, this journey might appear daunting.
But fear not—the process is more manageable than it seems. Here is an 8-step roadmap to guide you through the regulatory review and approval process for medical devices in most major markets.
8 Important Steps to Achieving Medical Device Approval
1. Define the Product
2. Identify Relevant Regulatory Requirements
3. Establish a Test Plan
4. Assemble Representative Samples and Accessories for Testing
5. Prepare the Required Documentation
6. Submit Device for Testing
7. Obtain Product Certifications
8. Obtain Regulatory Approval
Conclusion
The entire approval process can take several months to over a year. Following this roadmap helps ensure your device meets regulatory requirements, minimizing surprises and delays.(read
entire article)
View : 36 Times
Category : Business
