BSI
BSI Group
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 plays a pivotal role in developing and implementing standards that drive progress across industries.
**Expertise & scope**
* EUDAMED registration support
* UDI management and compliance
* Broader regulatory compliance services for medical devices
* Certification services
* Training programs for medical device manufacturers
* Focus on quality management, information security, environmental management, and occupational health and safety standards.
**Reputation / proof points**
* Established presence with a global community of experts.
* Recognized for expertise and standards development.
* Holds a Royal Charter, first awarded in 1929, outlining objectives to simplify, standardize, and improve business performance.
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 plays a pivotal role in developing and implementing standards that drive progress across industries.
**Expertise & scope**
* EUDAMED registration support
* UDI management and compliance
* Broader regulatory compliance services for medical devices
* Certification services
* Training programs for medical device manufacturers
* Focus on quality management, information security, environmental management, and occupational health and safety standards.
**Reputation / proof points**
* Established presence with a global community of experts.
* Recognized for expertise and standards development.
* Holds a Royal Charter, first awarded in 1929, outlining objectives to simplify, standardize, and improve business performance.
Additional information
BSI's approach to EUDAMED registration support is integrated with their broader expertise in medical device regulation and compliance. They offer comprehensive services that extend beyond just registration, encompassing UDI management and overall regulatory adherence. Their training programs are designed to equip manufacturers with the knowledge needed to navigate these complex requirements effectively. Engagement typically involves understanding the specific needs of the medical device manufacturer to tailor certification and compliance strategies.
Key Highlights
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BSI provides comprehensive support for EUDAMED registration, UDI management, and other regulatory compliance services for medical devices.
Source
“providing comprehensive medical device services including EUDAMED registration support, UDI management, and regulatory compliance services.”
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Offers both certification services and training programs for medical device manufacturers.
Source
“They offer both certification services and training programs for medical device manufacturers.”
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BSI's work is guided by a Royal Charter, established in 1929, focused on simplifying, standardizing, and improving business performance.
Source
“First awarded in 1929, the Royal Charter sets out our objectives: to simplify, standardize, and improve business performance.”
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Supports a global community of 13,000 experts in standards development and implementation.
Source
“We support a 13,000-strong global community of experts”
Certifications & Trust Signals
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BSI is recognized for its expertise and standards development.
Source
“Recognition for our expertise and standards”
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Adheres to high standards in corporate compliance and ethics, guided by integrity.
Source
“High Standards in Corporate Compliance, guided by Integrity”
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Holds a Royal Charter, demonstrating a long-standing commitment to standardization and business improvement.
Source
“the Royal Charter sets out our objectives: to simplify, standardize, and improve business performance.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking comprehensive EUDAMED registration support.
- Companies requiring assistance with UDI management and broader regulatory compliance.
- Organizations looking for certification and training services in the medical device sector.
How engagement typically works
- Consultative approach to understand specific client needs.
- Provision of tailored certification and training solutions.
- Partnership focused on achieving regulatory compliance and market access.
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 clients require a holistic approach to medical device compliance, not just isolated registration support.
HQ:
Reston, United States
Languages:
English
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Find 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, required documents, or timelines 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 (implied by description)
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