BSI

BSI Group
★★★★★ 1.9 / 5
• 28 reviews

BSI is a leading certification, testing, and training organization providing comprehensive medical device compliance services including importer/distributor compliance, MDR/IVDR consulting, and regulatory services. They offer both certification services and training programs for medical device manufacturers.

BSI stands as a premier training provider, specializing in management systems and organizational resilience. Their deep involvement in developing many of the world's leading standards translates into unparalleled expertise for their clients. With a commitment to delivering world-leading industry experts and innovative training solutions, BSI has earned high ratings from a vast number of clients. They offer a comprehensive suite of training courses designed to meet diverse organizational needs. Their training catalog includes specialized areas such as Aerospace AS9100:2016, Anti-Bribery, Artificial Intelligence (AI), Automotive IATF 16949:2016, Building Information Modelling (BIM), Business Continuity ISO 22301, Cloud Security, Cybersecurity, Energy Management ISO 50001, Environment ISO 14001, Environmental Health & Safety (EHS), and Food & Safety.

About

**Who they are**
BSI (EU MDR Training) is a premier training provider focused on management systems and organizational resilience, offering expertise in developing world-leading standards. They provide innovative training solutions across various industries.

**Expertise & scope**
* Expertise in developing world-leading standards.
* Offers innovative training solutions for diverse industries.
* Focus on quality management, information security, environmental management, occupational health and safety, and carbon footprint verification.
* Coverage extends to the EU and UK.

**Reputation / proof points**
* Recognized for innovation, expertise, and best practices globally.
* Holds awards and commendations for their work.
* Incorporated by Royal Charter.

Additional information

BSI (EU MDR Training) emphasizes the importance of standards in driving organizational progress and innovation. They highlight their role in shaping a resilient digital future, prioritizing safety, cybersecurity, and reliability. The organization actively engages in developing standards, inviting participation from industry experts to contribute to global benchmarks. Their training programs are designed to equip organizations with the knowledge to navigate complex regulatory landscapes and achieve excellence in management systems.

Key Highlights

  • Offers training courses for EU MDR. Source
    “BSI is a premier training provider for management systems and organizational resilience, offering expertise in developing world-leading standards.”
  • Provides expertise in developing world-leading standards. Source
    “BSI is a premier training provider for management systems and organizational resilience, offering expertise in developing world-leading standards.”
  • Coverage includes EU and UK markets. Source
    “Coverage: EU, UK”
  • Focuses on standards such as ISO 9001, ISO 27001, ISO 14001, ISO 45001. Source
    “Quality Management (ISO 9001) Information Security (ISO 27001) Environmental Management (ISO 14001) Occupational Health and Safety Management (ISO 45001)”

Certifications & Trust Signals

  • Incorporated by Royal Charter. Source
    “Incorporated by Royal Charter”
  • Recognized for innovation, expertise, and best practices. Source
    “An Award-Winning Company Having a Positive Impact for the Benefit of All; Garnering global praises for our innovation, expertise and best practices from the UK to Japan.”
  • Adheres to high standards in corporate compliance and ethics. Source
    “High Standards in Corporate Compliance, guided by Integrity”

Buyer Snapshot

Best for
  • Organizations seeking comprehensive medical device compliance support.
  • Companies needing guidance on MDR and IVDR regulations.
  • Businesses aiming for international certification and standards adherence.
How engagement typically works
  • Consultative approach to compliance challenges.
  • Partnership in achieving regulatory goals.
  • Provision of training and certification services.
Typical deliverables
  • MDR/IVDR compliance reports and strategies.
  • Certified management systems (e.g., ISO 9001, ISO 27001).
  • Regulatory guidance and documentation review.
  • Training materials and certification.
Good to know
  • Best when organizations require expert-led guidance on complex regulatory frameworks.
  • Suitable for companies operating within or expanding into the EU and UK markets.
HQ: Reston, United States
Languages: English
Timezones: Europe/London
Status: listed

Services & Capabilities

Importer & Distributor Compliance Support

Jurisdictions: EU, UK
Countries: GB, IE, DE, FR, NL, BE
Industries: Medical devices, Healthcare, Distribution
Portfolio: 26-100, 100+
Onboarding time: 7–18 days
Pricing model: Per project
Starting from: GBP 800
Included services: Training for economic operator obligations, Compliance gap scan, Audit readiness support
Training Available: Yes
Template Pack Available: No
Deliverables: Training
Training Format: Both
Role Coverage: Both

Additional importer_distributor_compliance Details

Role Coverage
Importer, Distributor
Supports MDR
true
Verification Support
Yes
Device Classes Supported
Class I, IIa, IIb, III
Supports IVDR
true
Storage Conditions Support
No
Onboarding Steps
The website content does not detail specific onboarding steps for compliance services, but it does mention involvement in standards development and training.
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