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Showing 1-10 of 14 results
Daniel Albahari

Introducing our new BioReg member – Jelena Markovic LL. B. & Literature Clinical Evaluation Report (CER) Expert

  • Posted by Daniel Albahari
  • Categories Blog
January 29, 2021
0

We are delighted to welcome Jelena, our new full-time employee. Jelena has unique expertise combining extensive working experience as a Legal Analyst and a Scientific Literature Librarian. Jelena will work on writing literature protocols and reports for the MDR Clinical …

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Breast implants
Daniel Albahari

Devices without a medical purpose: how do they fit into the MDR?

  • Posted by Daniel Albahari
  • Categories Blog
October 13, 2020
0

AUTHOR Daniel Albahari, CEO & Principal Regulatory Consultant, BioReg Services, Israel. KEYWORDS EU Medical Device Regulation; MedTech; Non-medical devices; Annex XVI; Clinical evaluation; Post-market surveillance; Risk management.  ABSTRACT In this article, we explore a newly introduced product category described in …

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Daniel Albahari

Presenting a BioReg Partner | Authorized Representative, mdi Europa GmbH

  • Posted by Daniel Albahari
  • Categories Blog
June 23, 2020
0

As you know, placing a new medical device on the market is the end result of long and laborious team work.  A medical device team can vary depending on the product type but it will almost always, without exception, include …

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Woman in a laboratory checking samples
Daniel Albahari

About the Class I MDR grace period & significant changes

  • Posted by Daniel Albahari
  • Categories Blog
March 26, 2020
0

As manufacturers of medical devices and sponsors struggle to meet MDR conformity, a second MDR amendment published at the end of 2019 may benefit some EU device manufacturers. In this blog we want to summarize what the MDR grace period …

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Plant breaking through concrete
Daniel Albahari

Could the FDA Breakthrough Program For Medical Devices Help You?

  • Posted by Daniel Albahari
  • Categories Blog
May 14, 2019
0

We think it could. Final guidance for FDA “Breakthrough Devices Program” was published in December 2018. As this could be potentially relevant for many medical devices in development, we thought it would be worthwhile bringing it to your attention. Ultimately, …

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Cannabis regulatory framework
Daniel Albahari

Cannabis Products – Regulatory Frameworks in US and EU

  • Posted by Daniel Albahari
  • Categories Blog
March 27, 2019
0

The purpose of this blog is to provide initial info about certain regulatory pathway options, or the lack of these, for products containing cannabis or for cannabis derived compounds in the United States and European Union. The reader should bear …

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New medical device regulation MDR
Daniel Albahari

Medical device clinical evaluation according to new MDR Medical Device Regulation

  • Posted by Daniel Albahari
  • Categories Blog
March 7, 2019
0

Clinical evaluation represents a methodologically sound ongoing procedure to collect, evaluate and examine the clinical data relevant to a medical device. As the application date for the new Medical Device Regulation MDR approaches, many clients have turned to us to …

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Veterinary Medical Devices Regulation
Daniel Albahari

Veterinary Medical Devices Regulation in EU & FDA

  • Posted by Daniel Albahari
  • Categories Blog
May 9, 2018
0

Veterinary medical devices regulation is a seldomly discussed topic and therefore BioReg Services have decided to share with you our knowledge and experience within the EU regulatory framework and veterinary medical device market. Let’s start with a comparison of the …

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Post market surveillance plan and Post market clinical follow up - PMS and PMCF plan
Daniel Albahari

PMS and PMCF Plans for Medical Devices and How to Design Them Efficiently?

  • Posted by Daniel Albahari
  • Categories Blog
February 7, 2018
0

In this post, we will try to summarize all you have to know in order to design Post Marketing Surveillance – PMS and Post Marketing Clinical Follow Up – PMCF plan for your medical device in compliance with the new …

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Regulation of mobile medical apps and general wellness products
Daniel Albahari

Regulation of Mobile Medical Apps & General Wellness Products

  • Posted by Daniel Albahari
  • Categories Blog
  • Comments 0 comment
July 11, 2017
99

Mobile Medical Applications (Apps), including General Wellness Products, can help people manage their own health and wellness, promote healthy living and gain access to useful information when and where they need it. These products are integral parts of our lives, …

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Latest Posts

Introducing our new BioReg member – Jelena Markovic LL. B. & Literature Clinical Evaluation Report (CER) Expert
29Jan2021
Breast implants
Devices without a medical purpose: how do they fit into the MDR?
13Oct2020
Presenting a BioReg Partner | Authorized Representative, mdi Europa GmbH
23Jun2020
bioreg services regulation affairs for startup companies

We are a regulatory affairs consulting firm dedicated to providing full regulatory support to medical device and biotechnology companies.

Address: 10 Shonei Halachot St., Old City, Jerusalem
Phone: +972-54-689-6868
Email 1: info@bioregservices.com
Email 2: daniel.albahari@bioregservices.com

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