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. They are committed to shaping society by developing a resilient digital future that respects privacy, safety, cybersecurity, and reliability.
**Expertise & scope**
* EUDAMED registration support
* UDI management
* Regulatory compliance services
* Certification services
* Training programs for medical device manufacturers
* Standards development and involvement
**Reputation / proof points**
* Established presence with a focus on quality management (ISO 9001), information security (ISO 27001), environmental management (ISO 14001), and occupational health and safety (ISO 45001).
* Recognized for innovation, expertise, and best practices globally.
* Operates with a commitment to high standards in corporate compliance and ethics, guided by integrity.
BSI is a global leader in certification, testing, and training, dedicated to helping organizations achieve excellence and navigate complex regulatory landscapes. They are committed to shaping society by developing a resilient digital future that respects privacy, safety, cybersecurity, and reliability.
**Expertise & scope**
* EUDAMED registration support
* UDI management
* Regulatory compliance services
* Certification services
* Training programs for medical device manufacturers
* Standards development and involvement
**Reputation / proof points**
* Established presence with a focus on quality management (ISO 9001), information security (ISO 27001), environmental management (ISO 14001), and occupational health and safety (ISO 45001).
* Recognized for innovation, expertise, and best practices globally.
* Operates with a commitment to high standards in corporate compliance and ethics, guided by integrity.
Additional information
BSI's approach to regulatory support emphasizes comprehensive solutions beyond just registration. They offer training programs designed to equip medical device manufacturers with the knowledge needed for ongoing compliance. Their involvement in standards development also positions them as a forward-thinking partner in navigating evolving regulatory requirements. Buyers engaging with BSI can expect a structured approach to compliance, leveraging their extensive experience in certification and testing.
Key Highlights
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Provides comprehensive medical device services including EUDAMED registration support and UDI management.
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.”
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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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Active involvement in standards development to improve business performance and address societal challenges.
Source
“How You Can Help Create the Standards That Make Society Better”
Certifications & Trust Signals
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Recognized for expertise and standards development.
Source
“Recognition for our expertise and standards”
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Holds a Royal Charter, established in 1901, to simplify, standardize, and improve 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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Adheres to high standards in corporate compliance and ethics, guided by integrity.
Source
“High Standards in Corporate Compliance, guided by Integrity”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EUDAMED registration support
- Organizations requiring comprehensive regulatory compliance services
- Companies looking for certification and training in quality and safety standards
How engagement typically works
- Consultative, providing expert guidance
- Solution-oriented, offering end-to-end support
- Educational, through training programs
Typical deliverables
- EUDAMED registration support
- UDI management strategies
- Regulatory compliance assessments
- Certification services
- Training materials and sessions
Good to know
- Best when organizations require deep expertise in medical device regulations and international standards.
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, 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
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