Medical Devices

Explore our library of medical device industry news articles, webinars, insights, and case studies.

Case Studies

Learn how Celegence has successfully supported global medical device organizations in navigating critical regulatory challenges and more.

Celegence Admin2021-02-09T16:46:19+00:00

Cost-efficient and High Quality CEP & CER Writing for Global Medical Device Companies

Celegence2021-02-16T13:34:02+00:00

Gap Analysis and CER Remediation - Celegence

Gap Analysis and CER Remediation for a Global Medical Device Company

Celegence2021-02-09T16:46:20+00:00

Medical Device Registration Project for a Global Medical Device Company in India, Bangladesh, Pakistan, Sri Lanka - Celegence

Medical Device Registration Project in India, Bangladesh, Pakistan and Sri Lanka

Celegence2021-02-09T16:46:20+00:00

New Medical Device Case Study - Life Science Regulations - Celegence

New Medical Devices Registration in ROW Countries

View More Medical Devices Case Studies

Webinars

Learn about upcoming medical device focused webinars, and watch previous broadcasts.

Clinical Evaluations for Unique Product Types Under the EU MDR – Dr. Pratibha Mishra’s Presentation

Clinical Evaluations for Unique Product Types Under the EU MDR – Dr. Pratibha Mishra’s Presentation

Celegence Admin2021-02-16T17:14:32+00:00December 10th, 2020|

SaMD, Brexit & Market Surveillance – EUDAMED Database Webinar

SaMD, Brexit & Market Surveillance – EUDAMED Database Webinar

Celegence2021-02-09T16:27:57+00:00November 17th, 2020|

UDI & Product Types of Immediate Concern – EUDAMED Database Webinar

UDI & Product Types of Immediate Concern – EUDAMED Database Webinar

Celegence Admin2021-02-09T16:27:57+00:00November 10th, 2020|

How to Start Preparing Your RA QA Team for The EUDAMED Database – Webinar Overview

How to Start Preparing Your RA QA Team for The EUDAMED Database – Webinar Overview

Celegence2021-02-09T16:27:57+00:00November 4th, 2020|

View More Medical Devices Webinars

News

The latest global news and insights of the medical devices industry from our expert global team.

Combination Products: Seeking a Notified Body Opinion According to MDR Article 117

Combination Products: Seeking a Notified Body Opinion According to MDR Article 117

Celegence2021-04-09T13:21:52+00:00April 9th, 2021|

Medical Device Approvals – FDA Vs EU MDR

Medical Device Approvals – FDA Vs EU MDR

Celegence2021-03-10T15:35:55+00:00March 10th, 2021|

Approach to Authoring a Clinical Evaluation Report Under the EU MDR

Approach to Authoring a Clinical Evaluation Report Under the EU MDR

Celegence Admin2021-02-25T21:17:12+00:00February 25th, 2021|

Clinical Evaluation Report – Introduction to Clinical Reports

Clinical Evaluation Report – Introduction to Clinical Reports

Celegence2021-02-09T16:25:51+00:00February 3rd, 2021|

View More Medical Devices News

Medical Devices

Case Studies

Cost-efficient and High Quality CEP & CER Writing for Global Medical Device Companies

Cost-efficient and High Quality CEP & CER Writing for Global Medical Device Companies

Gap Analysis and CER Remediation for a Global Medical Device Company

Gap Analysis and CER Remediation for a Global Medical Device Company

Medical Device Registration Project in India, Bangladesh, Pakistan and Sri Lanka

Medical Device Registration Project in India, Bangladesh, Pakistan and Sri Lanka

New Medical Devices Registration in ROW Countries

New Medical Devices Registration in ROW Countries

Webinars

Clinical Evaluations for Unique Product Types Under the EU MDR – Dr. Pratibha Mishra’s Presentation

Clinical Evaluations for Unique Product Types Under the EU MDR – Dr. Pratibha Mishra’s Presentation

SaMD, Brexit & Market Surveillance – EUDAMED Database Webinar

SaMD, Brexit & Market Surveillance – EUDAMED Database Webinar

UDI & Product Types of Immediate Concern – EUDAMED Database Webinar

UDI & Product Types of Immediate Concern – EUDAMED Database Webinar

How to Start Preparing Your RA QA Team for The EUDAMED Database – Webinar Overview

How to Start Preparing Your RA QA Team for The EUDAMED Database – Webinar Overview

News

Combination Products: Seeking a Notified Body Opinion According to MDR Article 117

Combination Products: Seeking a Notified Body Opinion According to MDR Article 117

Medical Device Approvals – FDA Vs EU MDR

Medical Device Approvals – FDA Vs EU MDR

Approach to Authoring a Clinical Evaluation Report Under the EU MDR

Approach to Authoring a Clinical Evaluation Report Under the EU MDR

Clinical Evaluation Report – Introduction to Clinical Reports

Clinical Evaluation Report – Introduction to Clinical Reports

Medical Device Resources

Pharmaceutical Resources

Schedule A Demo

Our Services

Combination Products: Seeking a Notified Body Opinion According to MDR Article 117