BN conseils
World Gold Council
The World Gold Council is the global authority on gold, driving progress and shaping policy for a responsible and accessible gold supply chain. They provide research, analysis, and insights to champion gold's role as a strategic asset.
The World Gold Council (WGC) is a membership organization that champions the role of gold as a strategic asset and drives progress for a responsible and accessible gold supply chain. Formed in 1987 by leading gold mining companies, the WGC provides expert research, analysis, commentary, and insights to enhance understanding of gold's use cases and possibilities. They are dedicated to shaping policy and setting principles for a sustainable gold market, serving the needs of market participants and promoting gold's value across cultural, financial, and industrial sectors globally. With a global presence, the WGC's mission is supported by three core pillars: improving understanding, improving access, and improving trust in the gold market. Their work involves analyzing supply and demand trends, addressing industry challenges through innovation, and ensuring gold remains a fit-for-the-future asset. The organization is committed to transparency and responsible practices throughout the gold supply chain, contributing to host economies and fostering economic, social, and environmental benefits.
About
**Who they are**
BN conseils is a consulting firm specializing in quality and regulatory affairs, led by Béatrice Najem, a regulatory affairs expert.
**Expertise & scope**
* Regulatory and quality expertise for medical devices (Class I, II, III).
* Regulatory strategy evaluation and clinical strategy support.
* Regulatory support for R&D and New Product Introduction (NPI) projects.
* Management of regulatory non-conformities and implementation of regulatory processes.
* Registration of medical devices with health authorities in the EU, CH, UK, and US.
* Technical file writing, updates, and submissions.
* Liaison with Notified Bodies for medical device certification.
* Conformity gap analysis against MDR (2017/745) and ISO 13485.
* Post-Market Surveillance (PMS) regulatory support.
* UDI process implementation and MDR compliance.
* Quality Management System (QMS) implementation and process compliance evaluations.
* Risk management implementation in compliance with ISO 14971, including benefit/risk analysis.
* Training on MDR, PRRC, and ISO 13485 in French and English.
* Experience in auditing suppliers (raw materials, CMOs, distributors) and managing CAPA plans.
* Management of quality events with regulatory impacts, including investigations and recalls.
**Reputation / proof points**
* Experience includes work with IPSEN CHC (383 M€, 1750 pers.) as Quality Regulatory Manager.
* Lecturer at Northeastern University (USA) and Rouen University (France) since 2021.
BN conseils is a consulting firm specializing in quality and regulatory affairs, led by Béatrice Najem, a regulatory affairs expert.
**Expertise & scope**
* Regulatory and quality expertise for medical devices (Class I, II, III).
* Regulatory strategy evaluation and clinical strategy support.
* Regulatory support for R&D and New Product Introduction (NPI) projects.
* Management of regulatory non-conformities and implementation of regulatory processes.
* Registration of medical devices with health authorities in the EU, CH, UK, and US.
* Technical file writing, updates, and submissions.
* Liaison with Notified Bodies for medical device certification.
* Conformity gap analysis against MDR (2017/745) and ISO 13485.
* Post-Market Surveillance (PMS) regulatory support.
* UDI process implementation and MDR compliance.
* Quality Management System (QMS) implementation and process compliance evaluations.
* Risk management implementation in compliance with ISO 14971, including benefit/risk analysis.
* Training on MDR, PRRC, and ISO 13485 in French and English.
* Experience in auditing suppliers (raw materials, CMOs, distributors) and managing CAPA plans.
* Management of quality events with regulatory impacts, including investigations and recalls.
**Reputation / proof points**
* Experience includes work with IPSEN CHC (383 M€, 1750 pers.) as Quality Regulatory Manager.
* Lecturer at Northeastern University (USA) and Rouen University (France) since 2021.
Additional information
BN conseils provides comprehensive support for medical device regulatory compliance, particularly focusing on the EU MDR. Their services encompass the entire product lifecycle, from initial strategy and R&D support through to post-market surveillance and registration. They emphasize a strong foundation in risk management, adhering to ISO 14971 standards, and offer training to ensure client teams are well-versed in current regulations. Engagement typically involves detailed project work, process implementation, and direct support for regulatory submissions and interactions with authorities and Notified Bodies.
Key Highlights
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Expertise in ISO 13485, ISO 14971, and EU MDR.
Source
“ISO13485 ISO14971 MDR”
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Experience with regulatory strategy, technical file writing, and submissions for Class I, II, and III medical devices.
Source
“Regulatory strategy evaluation, clinical strategy Regulatory support to R&D teams during NPI projects Registration of MD with authorized representatives and health authorities EU/ CH/ UK/ US Technical file writing, update, and submissions”
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Provides quality and regulatory training in French and English.
Source
“Quality & regulatory training in French & English (MDR, PPRC, Iso 13485)”
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Experience in managing quality events, including complaints and recalls, and implementing CAPA plans.
Source
“Management of quality events with regulatory impacts (e.g. complaints, recalls, changes, deviations, stability failures ,...) and ensure that the corresponding investigations are correctly performed and CAPA associated implemented.”
Certifications & Trust Signals
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Over 5 years of experience as a Quality & Regulatory Manager at IPSEN CHC.
Source
“2016 – 2021 (5 years) IPSEN CHC (383 M€, 1750 pers.) Quality regulatory manager”
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Currently serving as CEO and Regulatory/Quality expert at QuaRex Consulting LLC.
Source
“2023 Oct-Till now QuaRex Consulting LLC, MA, USA CEO - Regulatory/ Quality expert”
Buyer Snapshot
Best for
- Medical device manufacturers seeking MDR compliance support
- Companies needing assistance with technical file preparation and submissions
- Organizations requiring QMS implementation and regulatory process optimization
How engagement typically works
- Project-based consulting
- Regulatory strategy development
- Training and knowledge transfer
Typical deliverables
- Regulatory strategy reports
- Technical documentation packages
- QMS documentation and procedures
- Audit reports and CAPA plans
- Training materials
Good to know
- Best when requiring specialized expertise in EU MDR and ISO 13485.
HQ:
London, GB
Languages:
English
Timezones:
UTC, GMT, BST
Status:
claimed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Named PRRC:
No
Additional prrc_service Details
Device Classes Supported
Class I, II, III
Supports MDR
Yes
Supports IVDR
No
PRRC Qualification Summary
Regulatory affairs expert with extensive experience in quality and regulatory projects, QMS implementation, risk management, and regulatory submissions. Holds expertise in ISO 13485 and ISO 14971, and MDR compliance.
Regulatory Experience
Extensive experience in regulatory affairs and quality management, including roles spanning from 2016 to present, with specific focus on medical device regulations and QMS.
Onboarding Steps
The onboarding process likely involves initial consultation to define project scope, evaluation of existing documentation and processes, and development of a tailored regulatory strategy. Specific steps would be determined based on client needs.
