BIOREG ServicesBIOREG Services
  • Home
  • About Us
  • Services
    • Regulatory Strategy
    • Pre-approval Services
    • Regulatory Applications
    • Post-approval Services
    • Quality support
  • EU-MDR
  • Our clients
  • Blog
  • Contact
  • Home
  • About Us
  • Services
    • Regulatory Strategy
    • Pre-approval Services
    • Regulatory Applications
    • Post-approval Services
    • Quality support
  • EU-MDR
  • Our clients
  • Blog
  • Contact

Blog

  • Home
  • Blog
  • Page 2
Showing 11-14 of 14 results
Regulation of homeopathic drugs in US and FDA
Daniel Albahari

Regulation of Homeopathic Drugs in the US

  • Posted by Daniel Albahari
  • Categories Blog
  • Comments 0 comment
July 4, 2017
93

Regulation of Homeopathic Products in FDA Many people ask me about the regulation of homeopathic drugs in the US and about the legal side of homeopathy in FDA in general. So, we’ve decided to provide more info on how the …

Read More
Medical device intended use and label and off-label promotion
Daniel Albahari

About Product Intended Use, Label and Off-Label Promotion for Medical Device and Drugs

  • Posted by Daniel Albahari
  • Categories Blog
  • Comments 0 comment
May 30, 2017
61

In this week’s blog, we will provide some basic clarification regarding product intended use, label and off-label promotion and their limitations. These issues are covered in many separate guideline documents and regulations issued by the FDA and other agencies (e.g. …

Read More
Medicinal substance levels in medical device - borderline products EU
Daniel Albahari

The Impact of Medicinal Substance Levels on Medical Devices and Borderline Product Classification in the EU

  • Posted by Daniel Albahari
  • Categories Blog
  • Comments 0 comment
May 17, 2017
10

This blog will help you to understand how medicinal substance levels may affect borderline product classification and, more specifically,medical devices incorporating a medicinal substance with an ancillary action. The status of many products on the “borderline” between medicinal products and …

Read More
How to submit a successful FDA 510k submission
Daniel Albahari

Successful FDA 510(k) submission – ultimate PREDICATE guide

  • Posted by Daniel Albahari
  • Categories Blog
  • Comments 0 comment
March 15, 2017
810

Writing a successful 510(K) FDA submission is a difficult and demanding task, but using my 10-word PREDICATE formula will make this challenge a lot easier for you. The following are the major steps you should consider in every FDA 510k …

Read More
  • <
  • 1
  • 2

Search

WEEKLY NEWSLETTER

Subscribe NOW and get useful blogs every week.

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

DISCLAIMER

Although we believe the information provided on our website is correct, BIOREG Services is not responsible for its accuracy.

The web pages are for the public use as background information, and are not provided as regulatory advice whatsoever.

Links to other websites are provided as of possible interest, but BIOREG Services is not responsible for the accuracy of their content.

QUICK LINKS

About Us
EU-MDR Help
Our Clients
Frequently Asked Questions

Blog
Contact

All Rights Reserved by Avokado.

  • Privacy
  • Sitemap