BSI

BSI Group
★★★★★ 1.9 / 5
• 28 reviews

BSI is a leading certification, testing, and training organization providing comprehensive medical device services including EUDAMED registration support, UDI management, and regulatory compliance services. They offer both certification services and training programs for medical device manufacturers.

BSI Training Academy is a leading provider of training solutions for management systems and organizational resilience. Leveraging their expertise in developing world-leading standards, they offer a comprehensive range of courses designed to meet diverse industry needs. Their offerings include specialized training in areas such as Aerospace AS9100:2016, Automotive IATF 16949:2016, Cybersecurity, Environmental Management ISO 14001, and many more. With a commitment to providing world-class industry experts and innovative training solutions, BSI Training Academy ensures a high-quality learning experience. They offer flexible learning formats, including virtual and on-demand courses, catering to the needs of professionals seeking to enhance their knowledge and skills. Clients consistently rate BSI highly for their expertise and the effectiveness of their training programs. For inquiries about their course catalog or specific training needs, BSI Training Academy can be contacted via their website or by phone. Their US office is located at 1950 Opportunity Way, Suite 900, Reston, VA 20190.

About

**Who they are**
BSI is a global leader in certification, testing, and training, dedicated to helping organizations achieve excellence and navigate complex regulatory landscapes. With a history rooted in standardization, BSI supports businesses in delivering better products and adhering to improved regulations.

**Expertise & scope**
* EUDAMED registration support
* UDI management and regulatory compliance services
* Certification services for medical device manufacturers
* Training programs for medical device manufacturers
* Development and application of international standards

**Reputation / proof points**
* Established in 1901, with a Royal Charter dating back to 1929, signifying a long-standing commitment to standardization and societal improvement.
* Supports a global community of over 13,000 experts.
* Focuses on shaping a resilient digital future, prioritizing privacy, safety, cybersecurity, and reliability.
* Offers expertise in various management systems including Quality Management (9001), Information Security (27001), Environmental Management (14001), and Occupational Health and Safety (45001).

Additional information

BSI's approach to EUDAMED registration support is integrated with their broader expertise in medical device regulation and compliance. They emphasize the importance of standards in ensuring product safety and market access. Buyers engaging with BSI can expect a structured process that leverages their deep understanding of regulatory requirements and certification frameworks. Their services are designed to assist manufacturers in meeting the complex demands of EUDAMED, ensuring that devices comply with EU regulations. BSI's commitment extends to providing training, which can empower manufacturers to manage their regulatory obligations more effectively.

Key Highlights

  • BSI provides comprehensive EUDAMED registration support, UDI management, and regulatory compliance services for medical device manufacturers. Source
    “BSI is a leading certification, testing, and training organization providing comprehensive medical device services including EUDAMED registration support, UDI management, and regulatory compliance services.”
  • The organization has a long history, with work on the first standard beginning in 1901 and a Royal Charter awarded in 1929. Source
    “Our story begins in 1901 when work on the first standard began. Since then, we’ve existed to have a positive impact on society.”
  • BSI supports a global community of over 13,000 experts in developing standards and driving progress. Source
    “We support a 13,000-strong global community of experts”

Certifications & Trust Signals

  • BSI is recognized for its expertise and standards development, holding numerous awards and commendations. Source
    “An Award-Winning Company Having a Positive Impact for the Benefit of All”
  • The organization adheres to high standards in corporate compliance and ethics, guided by integrity. Source
    “High Standards in Corporate Compliance, guided by Integrity”
  • BSI offers expertise in various management systems, including Quality Management (ISO 9001) and Information Security (ISO 27001). Source
    “Quality Management 9001 Information Security 27001”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking EUDAMED registration support.
  • Companies needing assistance with UDI management and regulatory compliance.
  • Organizations looking for certification and training in medical device regulations.
How engagement typically works
  • Consultative approach to regulatory challenges.
  • Leverages extensive standards development and certification experience.
  • Offers training to build internal compliance capabilities.
Typical deliverables
  • EUDAMED registration support (Actor, UDI/Devices, etc.)
  • UDI management strategies and implementation
  • Regulatory compliance assessments and guidance
  • Certification services
  • Customized training programs
Good to know
  • Best when organizations require comprehensive support for EU medical device regulations.
  • Suitable for companies that value established expertise and a structured approach to compliance.
HQ: Reston, United States
Languages: English
Timezones: Europe/Brussels
Claim status: Listed

Services & Capabilities

Best EUDAMED Registration| Compare & Get Quotes

Jurisdictions: EU
Countries: SE, DK, NL, FR, PL, IT, DE
Industries: Medical devices, IVD, SaMD, Manufacturing
Portfolio: 100+
Onboarding time: 1–10 days
Pricing model: Per project
Starting from: GBP 750
Included services: Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration: Yes
Supports UDI: Yes
Supports Data Load: Yes
Modules Supported: Actor/SRN, UDI/Devices
Supports Training Enablement: Yes
Data Load Support Level: Done-for-you
Turnaround SLA: Custom

Additional eudamed_reg_support Details

Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
The provided content does not detail specific onboarding steps for EUDAMED registration support.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Supports Actor Registration
true
Supports UDI
true
Supports Vigilance
No
Supports Clinical Investigations
No
Modules Supported
Actor, UDI/Devices
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