BioReg Services
BioReg Services is a boutique regulatory consultancy specializing in regulatory and quality challenges for medical devices and healthcare products. They help startups and established companies navigate complex regulations to bring their ideas to market.
BioReg Services is a boutique regulatory consultancy dedicated to addressing the regulatory and quality challenges associated with medical devices and other healthcare products. Their mission is to develop optimal regulatory strategies, aiming for shorter approval times and enhanced marketing potential for their clients' products. They offer specialized, fast-deliverable, and high-quality regulatory services, combining professional expertise with a personal approach to build lasting client relationships. They provide comprehensive regulatory consulting, including EU-MDR CE certification, EU MDR Clinical Evaluation, literature reviews, and Post-Market Surveillance (PMS) & Vigilance. BioReg Services also assists with ISO 13485 & QMSR, FDA Submissions, Risk Management, writing SOPs, Quality Agreements, and training. Their strategic advantage lies in identifying innovative solutions within the regulatory landscape, examining all potential avenues to develop the most beneficial product strategies. With a focus on professionalism, reliability, and client satisfaction, BioReg Services strives to be a trusted partner. They are committed to growing their business by embracing best practices and delivering client satisfaction, aiming to become a leading regulatory consultancy in Israel and a provider of choice in the EU and the U.S.
About
**Who they are**
BioReg Services is a boutique regulatory consultancy focused on navigating the complexities of regulatory and quality challenges for medical devices and healthcare products. They aim to assist both startups and established companies in bringing their innovations to market.
**Expertise & scope**
* Specializes in EU MDR & IVDR consulting.
* Offers expertise in EU MDR Clinical Evaluation.
* Provides support for ISO 13485 & QMSR.
* Assists with writing Standard Operating Procedures (SOPs) and Quality Agreements.
* Covers the role of Economic Operators.
* Conducts trainings and educational programs.
* Focuses on turning ideas into approved products.
**Reputation / proof points**
* Dedicated to providing full regulatory support to medical device and biotechnology companies.
* Emphasizes professionalism, reliability, mutual trust, and personal/professional integrity.
* Prioritizes client and end-user satisfaction, customer (CX), and user experience (UX).
* Believes quality is fundamental to creating and delivering high added value, adhering strictly to relevant regulations and standards.
BioReg Services is a boutique regulatory consultancy focused on navigating the complexities of regulatory and quality challenges for medical devices and healthcare products. They aim to assist both startups and established companies in bringing their innovations to market.
**Expertise & scope**
* Specializes in EU MDR & IVDR consulting.
* Offers expertise in EU MDR Clinical Evaluation.
* Provides support for ISO 13485 & QMSR.
* Assists with writing Standard Operating Procedures (SOPs) and Quality Agreements.
* Covers the role of Economic Operators.
* Conducts trainings and educational programs.
* Focuses on turning ideas into approved products.
**Reputation / proof points**
* Dedicated to providing full regulatory support to medical device and biotechnology companies.
* Emphasizes professionalism, reliability, mutual trust, and personal/professional integrity.
* Prioritizes client and end-user satisfaction, customer (CX), and user experience (UX).
* Believes quality is fundamental to creating and delivering high added value, adhering strictly to relevant regulations and standards.
Additional information
BioReg Services positions itself as a partner for companies seeking to streamline their regulatory pathways. They focus on developing optimal regulatory strategies to shorten approval times and enhance marketing potential. Their approach involves embracing best practices and the latest knowledge to foster solid partnerships and ensure client satisfaction. They are committed to contributing value through their work, aiming for meaningful and purposeful engagement with clients, users, employees, and the community.
Key Highlights
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Specializes in EU MDR and IVDR consulting.
Source
“EU MDR & IVDR Consulting”
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Provides support for EU MDR Clinical Evaluation.
Source
“EU MDR Clinical Evaluation”
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Offers assistance with ISO 13485 and QMSR.
Source
“ISO 13485 & QMSR”
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Focuses on helping bring ideas to approved products.
Source
“We turn your idea into approved product.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Startups navigating regulatory hurdles.
- Established companies seeking specialized regulatory support.
How engagement typically works
- Professional and reliable partnership.
- Focus on client and end-user satisfaction.
Typical deliverables
- EU MDR & IVDR consulting.
- Clinical evaluation support.
- ISO 13485 & QMSR guidance.
- SOP and Quality Agreement development.
- Economic Operator support.
- Regulatory trainings.
Good to know
- Best when requiring specialized regulatory and quality guidance for medical devices and healthcare products.
HQ:
Jerusalem, Israel
Languages:
English, Croatian
Timezones:
Europe/Zagreb
Claim status:
Listed
Services & Capabilities
Find PRRC Services | EU MDR/IVDR Providers & Quotes
Jurisdictions:
EU
Countries:
US, CA, EU, IL
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
1-5
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Starting from:
EUR 1,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Business hours
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
BioReg Services is a boutique regulatory consultancy that handles regulatory and quality challenges for medical devices and other healthcare products. They offer regulatory consulting for medical devices and other healthcare companies, including EU-MDR CE certification, EU MDR Clinical Evaluation, Literature review, PMS & Vigilance, ISO 13485 & QMSR, Writing SOPs, Quality Agreements, Economic Operators, Trainings & Education, FDA Submissions, and Risk Management. They aim to develop optimal regulatory strategies, achieving shorter approval times and greater marketing potential for their clients. Their vision is to be a cutting-edge, reliable regulatory consultancy for medical devices and other healthcare products, aspiring to become a leading boutique regulatory consultancy in Israel and a regulatory provider of choice in the EU and the U.S.
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Not explicitly stated
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Device Classes Supported
Not explicitly stated
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
The provided text does not detail specific PRRC qualifications, but highlights extensive experience in regulatory affairs for medical devices and biotechnology.
Regulatory Experience
The company focuses on regulatory and quality challenges for medical devices and healthcare products, with specific mention of EU MDR & IVDR consulting, EU MDR Clinical Evaluation, and ISO 13485 & QMSR.
