Home
By Industry
Medical Device
New Product Approval
Compliance Assessment
Regulatory Gap Analysis
510(k) Submission
Compliance Audits
MDSAP
Data Integrity & GMP Consulting
Cybersecurity Compliance
ISO 13485
Clinical Evaluation Report (CER)
Outsourced Quality Support
Regulatory due diligence
Regulatory Agency Action Response
Import & Export Support
Clinical Trial Management Support
Post Approval Support
SaMD & IVD
IVD-LDT Regulatory Consulting
Cosmetic
Food
Hospitals/Clinics
Resources
Elexes Blog
Industry News
Case Studies
Videos
Infographics
About Us
Menu
Home
By Industry
Medical Device
New Product Approval
Compliance Assessment
Regulatory Gap Analysis
510(k) Submission
Compliance Audits
MDSAP
Data Integrity & GMP Consulting
Cybersecurity Compliance
ISO 13485
Clinical Evaluation Report (CER)
Outsourced Quality Support
Regulatory due diligence
Regulatory Agency Action Response
Import & Export Support
Clinical Trial Management Support
Post Approval Support
SaMD & IVD
IVD-LDT Regulatory Consulting
Cosmetic
Food
Hospitals/Clinics
Resources
Elexes Blog
Industry News
Case Studies
Videos
Infographics
About Us
Get Quote
Home
By Industry
Medical Device
New Product Approval
Compliance Assessment
Regulatory Gap Analysis
510(k) Submission
Compliance Audits
MDSAP
Data Integrity & GMP Consulting
Cybersecurity Compliance
ISO 13485
Clinical Evaluation Report (CER)
Outsourced Quality Support
Regulatory due diligence
Regulatory Agency Action Response
Import & Export Support
Clinical Trial Management Support
Post Approval Support
SaMD & IVD
IVD-LDT Regulatory Consulting
Cosmetic
Food
Hospitals/Clinics
Resources
Elexes Blog
Industry News
Case Studies
Videos
Infographics
About Us
Menu
Home
By Industry
Medical Device
New Product Approval
Compliance Assessment
Regulatory Gap Analysis
510(k) Submission
Compliance Audits
MDSAP
Data Integrity & GMP Consulting
Cybersecurity Compliance
ISO 13485
Clinical Evaluation Report (CER)
Outsourced Quality Support
Regulatory due diligence
Regulatory Agency Action Response
Import & Export Support
Clinical Trial Management Support
Post Approval Support
SaMD & IVD
IVD-LDT Regulatory Consulting
Cosmetic
Food
Hospitals/Clinics
Resources
Elexes Blog
Industry News
Case Studies
Videos
Infographics
About Us
Get Quote
News
Home
News
February 6, 2024
Elexes Team
QMSR Final Rule Issued by FDA with 2-years Transition Period
Read More
Post a Comment
January 19, 2024
Elexes Team
FDA Issues First Mass Drug Imports To States From Canada
Read More
Post a Comment
November 30, 2023
Team Elexes
Three New International Medical Device Software Security Standards Issued By FDA
Read More
Post a Comment
September 29, 2023
Elexes Team
Women is the future of medtech innovations
Read More
Post a Comment
September 18, 2023
Elexes Team
FDA’s new draft guidance on best practices for selecting predicate devices for 510(k) notifications!
Read More
Post a Comment
August 3, 2023
Team Elexes
A Final Guidances On Device Shortage Reporting & Computational Modeling Published By FDA
Read More
Post a Comment
July 31, 2023
Elexes Team
Extension to EU MDR transition period finalized!
Read More
Post a Comment
July 27, 2023
Elexes Team
Opill, an Over-The-Counter (OTC) drug was approved by the US F.D.A.
Read More
Post a Comment
March 1, 2023
Elexes Team
Companion Diagnostics (CDx): The future of safe and effective therapies!
Read More
Post a Comment
September 30, 2022
Elexes Team
Health Canada’s Regulatory requirements for UV light-emitting products with claims pertaining to Covid -19
Read More
Post a Comment
June 15, 2021
Elexes Team
3D Medical Imaging | Revolutionizing The Vision of Medicine
Read More
Post a Comment
June 3, 2021
Elexes Team
Addressing Duodenoscope contamination – An FDA Initiative
Read More
Post a Comment
June 3, 2021
Elexes Team
17 years Journey – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse (POP)
Read More
Post a Comment
June 3, 2021
Elexes Team
Is EU-MDR coming later? EU MDD to MDR – A major change
Read More
Post a Comment
April 25, 2021
Elexes Team
Breakthroughs in Cardiovascular Treatments – Where Science becomes the Saviour
Read More
Post a Comment
July 9, 2024
Elexes Team
Understanding FDA Recalls for Medical Devices
Read More
Post a Comment
July 5, 2024
Elexes Team
How to Get FDA Approval for Medical Devices?
Read More
Post a Comment
July 3, 2024
Team Elexes
A Guide to Training Management for Medical Devices
Read More
Post a Comment
June 24, 2024
Vaishali
Predicate Device: What is it and How to Choose the Right One?
Read More
Post a Comment
June 20, 2024
Vaishali
The Importance of Conducting Internal Audits in Medical Device Companies
Read More
Post a Comment
June 19, 2024
Elexes Team
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours
Read More
Post a Comment
1
2
3
…
25
Load More
+1 408-475-8091
jennifer@elexes.com
Contact
Book an Appointment
Latest Portfolio
Understanding FDA Recalls for Medical Devices
How to Get FDA Approval for Medical Devices?
A Guide to Training Management for Medical Devices
Predicate Device: What is it and How to Choose the Right One?
The Importance of Conducting Internal Audits in Medical Device Companies
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours
Different types of 510k submissions | Special, Abbreviated vs Traditional 510(k)
The Role of a Regulatory Director & Why the Idea of Fractional Regulatory Affairs Manager is Catching Up?
A Basic Guide to Mock FDA Inspections/Audits
8 Common Healthcare Compliance & Regulatory Challenges & Their Solutions
Streamlining Healthcare Regulatory Compliance | Everything You Must Know
Most Trusted Medical Device Regulatory Consultants in The US (2024 Update)
Everything to know about JCI Accreditation | Overview, Benefits, How to get one?
CE Marking Strategy For Medical Devices | (EU CE Mark)
Do’s and Don’ts in a Quality Audit
Need Any Help? Or Looking For an Agent
9806071234
sendmail@example.com
Working Hours :
Sun-monday, 09am-5pm
© 2024 Elexes. All Rights Reserved.