Operon Strategist

Operon Strategist Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Operon Strategist, Medical and health, MSR Capital , Office No:14, 4th Floor, Old Mumbai Pune Highway Pimpri-Chinchwad Pune, Pune.

✅ Stay EU MDR Compliant in Germany — 2025 Edition! 🇩🇪 Ensure your medical devices meet all regulatory standards under MD...
25/06/2025

✅ Stay EU MDR Compliant in Germany — 2025 Edition! 🇩🇪
Ensure your medical devices meet all regulatory standards under MDR 2017/745 with our step-by-step compliance checklist. From classification to EUDAMED registration, Operon Strategist guides you every step of the way.

https://operonstrategist.com/en-de/eu-mdr-compliance-checklist/?utm_source=Linkedin&utm_medium=organic+social&utm_campaign=What+Is+MDR+Compliance%3F

💼 Your trusted partner for MDR success in Germany.
📞 Contact us today to stay audit-ready & market-safe!

Legacy IVD Devices & IVDR Compliance – Are You Ready?The transition from IVDD to IVDR is more than just a regulatory cha...
25/06/2025

Legacy IVD Devices & IVDR Compliance – Are You Ready?
The transition from IVDD to IVDR is more than just a regulatory change it’s a call for action. Manufacturers of legacy devices must now meet stricter IVDR requirements to maintain EU market access.
In our latest blog, we break down 6 essential steps to help you stay compliant and future-ready.

📖 Read now: https://operonstrategist.com/how-to-get-legacy-devices-to-ivdr-compliance/?utm_source=Linkedin&utm_medium=organic+social&utm_campaign=How+to+Get+Legacy+Devices+to+IVDR+Compliance

✅ Don’t risk market withdrawal. Get expert support🔬 from Operon Strategist your trusted medical device regulatory consultant.

Legacy IVD Devices & IVDR Compliance – Are You Ready?The transition from IVDD to IVDR is more than just a regulatory cha...
25/06/2025

Legacy IVD Devices & IVDR Compliance – Are You Ready?

The transition from IVDD to IVDR is more than just a regulatory change it’s a call for action. Manufacturers of legacy devices must now meet stricter IVDR requirements to maintain EU market access.
In our latest blog, we break down 6 essential steps to help you stay compliant and future-ready.

📖 Read now: https://operonstrategist.com/how-to-get-legacy-devices-to-ivdr-compliance/?utm_source=Linkedin&utm_medium=organic+social&utm_campaign=How+to+Get+Legacy+Devices+to+IVDR+Compliance

✅ Don’t risk market withdrawal. Get expert supp🔬ort from Operon Strategist your trusted medical device regulatory consultant.

This International Yoga Day, let's align body, mind, and compliance. At Operon Strategist, we believe balance is the key...
21/06/2025

This International Yoga Day, let's align body, mind, and compliance. At Operon Strategist, we believe balance is the key—whether in wellness or regulatory success. 🧘‍♂️🌿

They fix everything from broken toys to big dreams.This Father’s Day, we celebrate the heroes who lead with heart and bu...
15/06/2025

They fix everything from broken toys to big dreams.
This Father’s Day, we celebrate the heroes who lead with heart and build with vision.

From all of us at Operon Strategist 💙🔧

🔍 Process Validation in 2025: No Longer Optional, But EssentialWith global regulators tightening compliance standards, m...
14/06/2025

🔍 Process Validation in 2025: No Longer Optional, But Essential

With global regulators tightening compliance standards, medical device manufacturers must adopt a data-driven, lifecycle-based validation approach to ensure consistent product quality and patient safety.

From IQ, OQ, PQ to Continuous Process Verification (CPV), our latest guide breaks down everything you need to know about meeting 2025’s validation expectations under FDA QSR, EU MDR, ISO 13485:2025, and EDA Egypt.

💡 Operon Strategist offers expert support from Validation Master Plans to revalidation strategies ensuring you're always audit-ready and globally compliant.

📘 Read the full guide and get ahead of the compliance curve.
👉https://operonstrategist.com/process-validation-in-medical-device/?utm_source=Linkedin&utm_medium=organic+social&utm_campaign=Process+Validation+in+Medical+Device+Manufacturing

📞 Contact Us:📧 Email: bdsales@operonstrategist.com
📱 Phone: +91 87679 80322 | +91 90280 43428 | +91 93252 83428

📄 When Should You Submit a US FDA 510(k)? Timing isn’t just important it’s strategic.A well-prepared and timely 510(k) s...
12/06/2025

📄 When Should You Submit a US FDA 510(k)?

Timing isn’t just important it’s strategic.

A well-prepared and timely 510(k) submission can mean faster market access, fewer delays, and stronger regulatory confidence. Whether you're launching a new device or modifying an existing one, understanding when and how to file can make all the difference.

✅ Faster approvals
✅ Fewer review hurdles
✅ Competitive edge in the U.S. market

We break it all down from identifying predicate devices to choosing between Traditional, Special, or Abbreviated 510(k) routes.

🔍 Read the full guide to learn how to time your FDA submission for maximum impact:

https://operonstrategist.com/when-to-submit-a-usfda-510k/?utm_source=Linkedin&utm_medium=organic+social&utm_campaign=When+to+Submit+a+USFDA+510%28k%29

📞 Contact Us:📧 Email: bdsales@operonstrategist.com
📱 Phone: +91 87679 80322 | +91 90280 43428 | +91 93252 83428

📅 Operon Strategist is coming to WHX Miami 2025!Let’s talk about how we can simplify your regulatory challenges and get ...
11/06/2025

📅 Operon Strategist is coming to WHX Miami 2025!
Let’s talk about how we can simplify your regulatory challenges and get your MedTech devices to market faster.

Looking forward to connecting with you!
📞 Contact Us:
📧 Email: bdsales@operonstrategist.com
📱 Phone: 9823283428

CDSCO Updates List of Laboratories for Performance Evaluation of IVD Medical Devices in IndiaUpdates The Central Drugs S...
10/06/2025

CDSCO Updates List of Laboratories for Performance Evaluation of IVD Medical Devices in India

Updates The Central Drugs Standard Control Organization (CDSCO) has recently released an updated and expanded list of laboratories approved for performance evaluation of in vitro diagnostic (IVD) medical devices in India.

This update is critical for medical device manufacturers, importers, and startups planning to launch IVD products in the Indian market, as performance evaluation is a key component of the regulatory approval process under the Medical Device Rules, 2017.

The updated list categorizes testing labs based on the specific diseases or conditions the IVD kits are intended to detect. This move is expected to improve access to reliable performance testing services across the country, ensuring faster time to market for new diagnostic devices. Looking For a Medical Device Regulatory Consultant?

Know More:
https://operonstrategist.com/cdsco-updates-list-of-laboratories-for-performance-evaluation-of-ivd-medical-devices-in-india/?utm_source=Linkedin&utm_medium=organic+social&utm_campaign=CDSCO+Updates+List+of+Laboratories

📞 Contact Us:📧 Email: bdsales@operonstrategist.com
📱 Phone: +91 87679 80322 | +91 90280 43428 | +91 93252 83428

Operon Strategist is coming to WHX Miami 2025!Let’s discuss how we can help you simplify your regulatory journey FDA, EU...
09/06/2025

Operon Strategist is coming to WHX Miami 2025!
Let’s discuss how we can help you simplify your regulatory journey FDA, EU MDR, UKCA, CDSCO & more.

📞 Contact Us:📧 Email: bdsales@operonstrategist.com
📱 Phone: 9823283428

hashtag hashtag hashtag hashtag hashtag hashtag hashtag hashtag

🌍 Happy World Environment Day from Operon Strategist! 🌱As a regulatory consulting partner in the medical device industry...
05/06/2025

🌍 Happy World Environment Day from Operon Strategist! 🌱

As a regulatory consulting partner in the medical device industry, we believe that sustainability and compliance go hand in hand.

From supporting eco-conscious product designs to helping manufacturers meet environmental regulations like RoHS, REACH, and WEEE, we’re committed to building a greener, safer future one device at a time.

Let’s work together to ensure that innovation doesn’t cost the Earth.

🌿 Because protecting patient lives should never come at the expense of our planet.

23/09/2024

Is your country ready to embrace indigenous medical device manufacturing? 🌍 Discover how nations like Saudi Arabia, Oman, and India are revolutionizing healthcare by fostering local production, boosting innovation, and enhancing self-sufficiency. Read more in our latest blog!

https://operonstrategist.com/indigenous-medical-device-manufacturing/?utm_source=organic+social+&utm_medium=linkedin&utm_campaign=Indigenous+Medical+Device+Manufacturing%3A+A+Global+Push+Towards+Self-Sufficiency

Mail ID: enquiry@operonstrategist.com
Phone no: +91 9370283428

Address

MSR Capital , Office No:14, 4th Floor, Old Mumbai Pune Highway Pimpri-Chinchwad Pune
Pune
411018

Opening Hours

Monday 10am - 6:30pm
Tuesday 10am - 6:30pm
Wednesday 10am - 6:30pm
Thursday 10am - 6:30pm
Friday 10am - 6:30pm

Telephone

+919028042834

Website

Alerts

Be the first to know and let us send you an email when Operon Strategist posts news and promotions. Your email address will not be used for any other purpose, and you can unsubscribe at any time.

Shortcuts

Share

Category