If you are looking for assistance with CE certification and EU MDR regulatory compliance, I recommend hiring BioReg Services and Daniel Albahari, the founder of this regulatory consultancy.
Daniel has been extremely knowledgeable, efficient & very approachable throughout the process.
Daniel is very cooperative, and most importantly, he delivers all his obligations and beyond on time.
We got the EU MDR approval for our three class I medical devices on time. Thank you, Daniel!

Daniel and Jelena at BIOREG Services have just completed a big job for our company in getting us MDR compliant. The project was too big for us to do internally and we lacked the technical expertise. BIOREG stepped in and took care of everything. Their communication with us, as well as our Authorized Representative, was all very professional and moved along at a good pace throughout the project.

We are impressed enough with their work that we intend to use their services to get us ISO 13485 compliant in the near future.

If you are looking for help on any compliance or regulatory issues, I would not hesitate to use their services.

I have worked with Daniel Albahari for almost a year now and could not be happier with his services. He is always approachable, replies quickly and has helped us a lot in registering Cosmetic and food supplement products in Israel, formula reviews and finding local laboratories/warehouses and many more things associated with Israel regulatory/import requirements. Daniel is a pleasure to work with and very well knowledgeable in his field of work. I do recommend him highly and looking forward to continuing work together in the future.

Daniel from Bioreg Services has been, without a doubt, the pillar of support we needed in our path towards MDR conformity concerning our medical devices. In a time of ever more, demanding regulations, Daniel has been both extremely knowledgeable and efficient while simultaneously being incredibly approachable. He was able to determine our strengths and weaknesses quickly as well as give us custom-tailored advice on which direction we should be heading. We were able to rely on Daniel’s guidance, knowing that he was always there to support our team in surmounting any regulatory hurdles we came across. We will certainly be working with Daniel again in the future.

Mr. Daniel is simply awesome. He completely understood our situation and worked accordingly. Daniel helped us in identifying the most cost effective and fastest way in achieving medical approval for our devices.

Daniel,

Many thanks for prompt and efficient service! Great Job!

I have been working with Daniel for several months and can already highly recommend him as an excellent source of regulatory expertise. He is highly professional, carries out work in an extremely  timely manner without this affecting the quality of his work. I plan to continue  to use Daniel’s expertise and services throughout our entire development process.

I had the privilege of working with Daniel on several projects. Daniel is a very smart, talented regulatory professional, who has a skill that all great consultants must have – the ability to present a clear regulatory landscape and determine regulatory solutions and challenges that are most critical to the product’ success. He also knows how to simplify complex regulatory language and educate all team players to execute on the fine details of the regulatory plan. I appreciate Daniel’s open style and his ability to clearly communicate. I enjoyed working with Daniel and would be very happy to have him on board in the future projects.

I was lucky to have Daniel on board for several regulatory projects including bone products, OTC and prescription dental devices and food supplements. Daniel’s proactive approach and innovative solutions were extremely valuable and helped us to determine the most beneficial regulatory strategy.

I have worked with Daniel on a number of projects over the last few years. He is highly professional with a deep knowledge of regulatory affairs. We have requested an analysis of several issues with varying complexity, but regardless his work is always of very high quality and prepared according to agreed timelines. I highly recommend Daniel as a source of regulatory expertise and look forward to working with him again in the future.

I have known Daniel as co-worker for about four years. Daniel is very skilled in the field of drug regulation and most familiar with FDA and EMEA rules and guidelines. Furthermore, Daniel has developed knowledge and proficiency in searching, analyzing and selecting relevant information needed to support regulatory requirements. Aside from his profound professional skills, Daniel is an intelligent, open-minded, honest, dependable and very pleasant to work with.

Daniel’s regulatory expertise in the general wellness product area and attention to details were tremendously valuable for us. He is able to quickly understand the project objectives and priorities and provide important clarifications and contributions for the product claim possibilities.

Daniel prepared for us a medical device dossier. He has run all accompanying registration tasks independently until full completion thereby obtaining product registration certificate (CE marking) as requested for the marketing of medical device product in EU. Daniel handled this and other diverse and complex tasks in knowledgeable and efficient manner, always responsive to provide timely support.

I have known Daniel Albahari professionally for approximately two years. We have worked together on numerous projects involving regulatory activities in the United States, Canada and the European Union. I have found him to be a tireless, thoroughly dedicated colleague with deep expertise in the applicable regulations. We recently were able to obtain a 510(k) approval for a wound care hydrogel in the United States. Without Daniel’s efforts the product had no chance for approval. We also recently needed to obtain guidance for the type of device filing in the European Union for a mid-size pharmaceutical/dental company. Daniel was able to research the literature and provide a compelling argument in favor of our recommendation.

He was also instrumental in obtaining IND clearance with CDER at FDA for a new oral mucositis rinse. These are just a few examples of the depth of his regulatory expertise and commitment to the job.  I strongly recommend and truly enjoy working with such a professional.

I was very fortunate to have Daniel Albahari on board on several projects throughout the preparation of pre-IND package, and IND submission, including clinical study report and protocol processes. Daniel’s regulatory and quality expertise in this area, together with his attention to detail, was of tremendous value to us.

Daniel was able to provide a very knowledgeable and efficient approach to the work while keeping within the scheduled timeframes. I’m very recommending Daniel as an expert in these regulatory activities.

I had opportunity to work with Daniel on various quality projects in the company. Daniel is an out of the box thinker with a very strong quality background in the world of drug and medical device development.

I was very fortunate to have Daniel working on my project. Daniel is a knowledgeable, pro-active, analytical and diligent regulatory affairs professional. A result driven team player with strong work ethics and proven abilities in meeting challenges efficiently.

It was my pleasure to work with Daniel on establishing a quality system for a new veterinary venture. He performed an excellent professional work delivering the required service on time. Daniel has a superb attitude, availability and qualification.