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Posted by Sheila on August 11, 2024 at 7:37pm 0 Comments 0 Likes
Saudi Arabia SFDA Guidance on UDI (Unique Device Identification) effective from 01, October ,2021. The aim of guidance is to improve patients’ safety by applying standardised and globally accepted identification of medical devices.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on January 5, 2022 at 10:56am — No Comments
Are you looking forward to starting the manufacturing of blood collection tubes business? Operon Strategist is a medical device consulting company that provides turnkey services guidance to various manufacturers in the healthcare industry to ensure strategic development
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on January 5, 2022 at 10:25am — No Comments
FDA 510k is a premarket approval process made by FDA to signify that the device to be marketed is at least as safe and effective, substantially equivalent, to a lawfully marketed device (21 CFR 807.92) that is not subject to premarket approval.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on January 2, 2022 at 9:03am — No Comments
we at operon strategist would help you to take a step closer to successfully launch your product into market and to transform healthcare.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on January 2, 2022 at 8:51am — No Comments
Operon Strategist will help you with the CDSCO Wholesale and Manufacturing License process.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on December 29, 2021 at 5:36am — No Comments
If you are looking for FDA medical device approval process for your medical device then you are in the right place. Operon strategist provide consultantion on FDA medical device approval process.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on December 29, 2021 at 5:22am — No Comments
Are you looking forward to manufacturing the disposable syringe business? Operon Strategist is a medical device consulting company which provides regulatory guidance to various manufacturers in the healthcare industry to ensure strategic development.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on December 3, 2021 at 7:18am — No Comments
Are you looking forward to starting the manufacturing of dental implant layout design? Operon Strategist is a medical device consulting company that provides turnkey services guidance to various manufacturers in the healthcare industry to ensure strategic development
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on December 3, 2021 at 6:48am — No Comments
Are you looking forward to starting the manufacturing of orthopaedic implants layout design? Operon Strategist is a medical device consulting company that provides turnkey services guidance to various manufacturers in the healthcare industry to ensure strategic development
Contact details –
Phone no - 93702 83428
Mail id – [email protected]
Visit-…
Added by meeraoperon on December 3, 2021 at 6:27am — No Comments
Are you looking forward to starting the manufacturing of blood collection tubes business? Operon Strategist is a medical device consulting company that provides turnkey services guidance to various manufacturers in the healthcare industry to ensure strategic development
Contact details –
Phone no - 93702 83428
Mail id – [email protected]
Visit-…
Added by meeraoperon on December 3, 2021 at 5:22am — No Comments
Operon Strategist has a team of trained professionals that work according to set standards and constantly upgrading their work techniques that assure meeting customer requirements timely and as per defined quality standards.
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Phone no - 93702 83428
Mail id – [email protected]
Added by meeraoperon on November 26, 2021 at 1:56am — No Comments
Get the right consultation for obtaining the CDSCO manufacturing license for Medical Device in India with Operon Strategist.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on November 24, 2021 at 6:54am — No Comments
Operon Strategist helps manufacturers develop their quality management system as per the requirements of ISO 15378.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on November 17, 2021 at 1:38am — No Comments
Operon Strategist the leading medical device 21 CFR 820.30 design control consultants have extensive experience with the practical implementation of design controls regulation for developing new design control processes or for making improvements to existing processes.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on November 17, 2021 at 1:26am — No Comments
QMS certification service including QMS certification training, layout designs, manufacturing and postmarket support as we have regulatory expertise in auditing, executing and maintaining all features.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on November 17, 2021 at 1:11am — No Comments
An Import license is issued for import of medical devices from other countries to India. Both the foreign company and Indian company jointly need to submit the documentation for the medical device and manufacturing unit.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on November 13, 2021 at 4:02am — No Comments
As ISO 13485 consultant we provide guidance about QMS for medical device industries and we make sure that our clients know the benefits of ISO 13485 Certification for their organization.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on November 10, 2021 at 3:50am — No Comments
Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on November 10, 2021 at 3:49am — No Comments
Medical devices design and development is the urgent stage for its prosperity. Operon strategist is there to guide you with the design consulting for medical devices.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on November 10, 2021 at 3:48am — No Comments
The N-95 masks and gowns FDA registration is collaborating with manufacturers of surgical masks and gowns to better understand the current supply chain issues related to the COVID-19 outbreak, and to avoid any widespread shortages of these products.
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Phone no - 93702 83428
Mail id – [email protected]
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Added by meeraoperon on October 29, 2021 at 5:42am — No Comments
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