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 innovative ideas into approved products.
**Expertise & scope**
* Navigating regulatory and quality challenges for medical devices and healthcare products.
* Supporting startups and established companies in bringing their products to market.
* Providing full regulatory support for medical device and biotechnology companies.
* Expertise in EU MDR & IVDR consulting, including clinical evaluations.
* Assistance with ISO 13485 and QMSR compliance.
* Services include writing SOPs, quality agreements, and addressing economic operator responsibilities.
* Offering trainings and educational programs.
**Reputation / proof points**
* Focus on startup businesses to handle regulatory affairs.
* Commitment to developing optimal regulatory strategies for shorter approval times and enhanced marketing potential.
* Emphasis on professionalism, reliability, mutual trust, and personal/professional integrity.
* Prioritization of client and end-user satisfaction, welfare, and safety.
* Belief that quality is fundamental to delivering high added value, with strict adherence to relevant regulations and standards.
BioReg Services is a boutique regulatory consultancy focused on guiding medical device and healthcare product companies through complex regulatory landscapes. They specialize in transforming innovative ideas into approved products.
**Expertise & scope**
* Navigating regulatory and quality challenges for medical devices and healthcare products.
* Supporting startups and established companies in bringing their products to market.
* Providing full regulatory support for medical device and biotechnology companies.
* Expertise in EU MDR & IVDR consulting, including clinical evaluations.
* Assistance with ISO 13485 and QMSR compliance.
* Services include writing SOPs, quality agreements, and addressing economic operator responsibilities.
* Offering trainings and educational programs.
**Reputation / proof points**
* Focus on startup businesses to handle regulatory affairs.
* Commitment to developing optimal regulatory strategies for shorter approval times and enhanced marketing potential.
* Emphasis on professionalism, reliability, mutual trust, and personal/professional integrity.
* Prioritization of client and end-user satisfaction, welfare, and safety.
* Belief that quality is fundamental to delivering high added value, with strict adherence to relevant regulations and standards.
Additional information
BioReg Services positions itself as a partner for companies seeking to streamline their path to market. Their approach emphasizes developing tailored regulatory strategies to accelerate product approvals and maximize market potential. They are dedicated to fostering client growth by enhancing both regulatory and business capabilities. The consultancy highlights its commitment to best practices, continuous learning, and building strong partnerships to ensure client satisfaction. Their focus on professionalism and reliability aims to establish them as a trusted advisor for navigating the intricacies of medical device and healthcare product regulations.
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 their 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, including clinical evaluations.
Source
“EU MDR & IVDR Consulting EU MDR Clinical Evaluation”
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Provides support for ISO 13485 and QMSR compliance.
Source
“ISO 13485 & QMSR”
Certifications & Trust Signals
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Emphasizes professionalism, reliability, and building mutual trust.
Source
“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, welfare, and safety.
Source
“We do not make any compromises regarding welfare and safety. Client and end-user satisfaction is our top priority”
Buyer Snapshot
Best for
- Startups and established companies needing regulatory guidance.
- Businesses seeking to navigate EU MDR & IVDR requirements.
- Companies requiring support with ISO 13485 and QMSR.
How engagement typically works
- Collaborative strategy development.
- Focus on client satisfaction and trust.
- Professional and reliable partnership.
Typical deliverables
- Regulatory strategy development.
- EU MDR & IVDR compliance support.
- ISO 13485 & QMSR implementation.
- SOP writing and quality agreements.
- Training and education programs.
Good to know
- Best when seeking 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 text implies significant regulatory experience through the services offered and the company's mission, but specific years are not stated.
