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 guiding medical device and healthcare product companies through complex regulatory landscapes. They specialize in transforming product ideas into approved market-ready solutions.
**Expertise & scope**
* Navigating regulatory and quality challenges for medical devices and healthcare products.
* Supporting startups and established companies in bringing new products to market.
* Developing optimal regulatory strategies to shorten approval times and enhance marketing potential.
* Providing full regulatory support for medical device and biotechnology companies.
* Expertise in EU MDR & IVDR consulting, EU MDR Clinical Evaluation, ISO 13485 & QMSR, Writing SOPs, Quality Agreements, and identifying Economic Operators.
* Offering Trainings & Education.
**Reputation / proof points**
* Focus on startup-focused businesses.
* Commitment to growing client companies' regulatory and business potential.
* Emphasis on professionalism, reliability, mutual trust, and personal/professional integrity.
* Prioritization of client and end-user satisfaction, alongside customer (CX) and user experience (UX).
* Strict adherence to relevant regulations and standards, believing quality is fundamental to high added value.
BioReg Services is a boutique regulatory consultancy focused on guiding medical device and healthcare product companies through complex regulatory landscapes. They specialize in transforming product ideas into approved market-ready solutions.
**Expertise & scope**
* Navigating regulatory and quality challenges for medical devices and healthcare products.
* Supporting startups and established companies in bringing new products to market.
* Developing optimal regulatory strategies to shorten approval times and enhance marketing potential.
* Providing full regulatory support for medical device and biotechnology companies.
* Expertise in EU MDR & IVDR consulting, EU MDR Clinical Evaluation, ISO 13485 & QMSR, Writing SOPs, Quality Agreements, and identifying Economic Operators.
* Offering Trainings & Education.
**Reputation / proof points**
* Focus on startup-focused businesses.
* Commitment to growing client companies' regulatory and business potential.
* Emphasis on professionalism, reliability, mutual trust, and personal/professional integrity.
* Prioritization of client and end-user satisfaction, alongside customer (CX) and user experience (UX).
* Strict adherence to relevant regulations and standards, believing quality is fundamental to high added value.
Additional information
BioReg Services emphasizes a partnership approach, aiming to build mutual trust and act as a reliable resource for their clients. They are dedicated to delivering client satisfaction by embracing best practices and the latest regulatory knowledge. Their approach involves working meaningfully and purposefully to create value for clients, users, employees, partners, and the community. They are committed to upholding welfare and safety without compromise, ensuring that quality is fundamental to their service delivery.
Key Highlights
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Specializes in regulatory and quality challenges for medical devices and healthcare products.
Source
“We are a regulatory affairs consulting firm dedicated to providing full regulatory support to medical device and biotechnology companies.”
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Focuses on helping startups and established companies bring ideas to market.
Source
“We are a startup-focused business handling the challenges of regulatory affairs so that your ideas can be turned into approved products.”
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Offers expertise in EU MDR & IVDR consulting and EU MDR Clinical Evaluation.
Source
“EU MDR & IVDR Consulting EU MDR Clinical Evaluation”
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Provides support for ISO 13485 & QMSR, SOP writing, and Quality Agreements.
Source
“ISO 13485 & QMSR Writing SOPs Quality Agreements”
Certifications & Trust Signals
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Emphasizes professionalism, reliability, and building mutual trust.
Source
“Professionalism & reliability We approach the business as professionally as possible. We build mutual trust and strive to be a highly trusted partner.”
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Prioritizes client and end-user satisfaction, along with customer and user experience.
Source
“Client and end-user satisfaction is our top priority, together with customer (CX) and user experience (UX).”
Buyer Snapshot
Best for
- Startups and established companies needing regulatory guidance for medical devices and healthcare products.
- Businesses seeking to navigate EU MDR and IVDR requirements.
- Companies looking for support in quality management systems (ISO 13485, QMSR).
How engagement typically works
- Partnership-focused approach
- Emphasis on trust and reliability
- Client-centric service delivery
Typical deliverables
- Regulatory strategy development
- EU MDR & IVDR consulting
- Clinical evaluation support
- Quality management system implementation (ISO 13485, QMSR)
- SOP writing and quality agreements
Good to know
- Best when clients require specialized regulatory and quality support for medical devices and healthcare products.
HQ:
Jerusalem, Israel
Languages:
English, Croatian
Timezones:
Europe/Zagreb
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get 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
Not explicitly stated
Regulatory Experience
The company positions itself as a regulatory affairs consulting firm dedicated to full regulatory support, implying significant experience, but specific years are not stated.
