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Elexes Team

Quality Management System

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Elexes Team

Steps involved in setting up a QMS

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How well do you know about the ingredients in your cosmetics?
Elexes Team

How well do you know about the ingredients in your cosmetics?

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Overcoming hurdles of launching an IVD in the European market
Elexes Team

Overcoming hurdles of launching an IVD in the European market

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Companion Diagnostics (CDx): The future of safe and effective therapies!
Elexes Team

Companion Diagnostics (CDx): The future of safe and effective therapies!

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10 tips to make your next Grant Application a success!
Elexes Team

10 tips to make your next Grant Application a success!

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Importing Cosmetic into the US? This is what you need to know!
Elexes Team

Importing Cosmetic into the US? This is what you need to know!

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How are Dietary Supplements regulated in the US?
Elexes Team

How are Dietary Supplements regulated in the US?

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Grant Process – All you need to know!
Elexes Team

Grant Process – All you need to know!

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Biologics, their Unique Characteristics, Applicable Requirements and Regulations
Elexes Team

Biologics, their Unique Characteristics, Applicable Requirements and Regulations

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Here’s what companies look for while developing an IVD for a critical marker
Elexes Team

Here’s what companies look for while developing an IVD for a critical marker

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Placing Class II Medical Devices in US Market
Elexes Team

Placing Class II Medical Devices in US Market

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How to approach the UK market with a drug monitoring device?
Elexes Team

How to approach the UK market with a drug monitoring device?

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DDx for effective diagnosis and the regulatory repercussions
Elexes Team

DDx for effective diagnosis and the regulatory repercussions

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Checkpoints for import and export of Medical Devices in the US
Elexes Team

Checkpoints for import and export of Medical Devices in the US

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Do’s and Don’ts in a Quality Audit
Elexes Team

Do’s and Don’ts in a Quality Audit

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Canadian Regulations for Medical Device Manufacturers and Importers
Elexes Team

Canadian Regulations for Medical Device Manufacturers and Importers

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What is so special about Harmonised Standards for medical devices and IVDs?
Elexes Team

What is so special about Harmonised Standards for medical devices and IVDs?

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Change is inevitable – The dynamic world of Medical Device Standards and compliance
Elexes Team

Change is inevitable – The dynamic world of Medical Device Standards and compliance

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ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation
Elexes Team

ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation

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BS EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes
Elexes Team

BS EN ISO 13485:2016/A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes

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FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!
Elexes Team

FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!

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Whether your product is cosmetic, a drug, or both? Learn the primary difference! (USA)
Elexes Team

Whether your product is cosmetic, a drug, or both? Learn the primary difference! (USA)

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What is Telemedicine & its benefits & approval
Elexes Team

What is Telemedicine & its benefits & approval

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HIPAA Law Violations: The Costly Consequences of Non-Compliance
Elexes Team

HIPAA Law Violations: The Costly Consequences of Non-Compliance

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Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups
Elexes Team

Navigating the Regulatory Landscape: Challenges and Opportunities for Medical Device and IVD Startups

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Pros and cons of hiring a medical device consultant
Elexes Team

Pros and cons of hiring a medical device consultant

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Latest Portfolio

A Final Guidances On Device Shortage Reporting & Computational Modeling Published By FDA

A Final Guidances On Device Shortage Reporting & Computational Modeling Published By FDA
Three New International Medical Device Software Security Standards Issued By FDA

Three New International Medical Device Software Security Standards Issued By FDA
Medical Device Design & Development Guide!

Medical Device Design & Development Guide!
International Standards for design to market for Wearable medical devices!

International Standards for design to market for Wearable medical devices!
CPSR for cosmetics what is this report and how do you get it

CPSR for cosmetics: what is this report and how do you get it?
What is GMP

What is GMP & Why it is important?
What are GMP Audits, its purpose and how to be prepared for them?

What are GMP Audits, its purpose and how to be prepared for them?
What is Cosmetic PIF & Key Components to be included in it?

What is Cosmetic PIF & Key Components to be included in it?
FDA Applications for Drugs and Biologics

5 Common FDA Applications for Drugs & Biologics
MDSAP Audit | Complete Guide!

MDSAP Audit | Complete Guide!

Women is the future of medtech innovations

Importance of regulatory strategy

FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!

Whether your product is cosmetic, a drug, or both? Learn the primary difference! (USA)

What is Telemedicine & its benefits & approval

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