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 Training Academy – Medical Devices is a premier provider of management systems and organizational resilience training, offering expert-led courses across various industries. They are dedicated to shaping society by developing a resilient digital future that respects privacy, safety, cybersecurity, and reliability.
**Expertise & scope**
* Expert-led courses in management systems and organizational resilience.
* Focus on developing a resilient digital future, emphasizing privacy, safety, cybersecurity, and reliability.
* Training in standards such as Quality Management 9001, Information Security 27001, Environmental Management 14001, and Occupational Health and Safety Management 45001.
**Reputation / proof points**
* Offers training in Quality Management 9001.
* Offers training in Information Security 27001.
* Offers training in Environmental Management 14001.
* Offers training in Occupational Health and Safety Management 45001.
* Offers training in Carbon Footprint Verification 14064-1.
* Operates globally, with a coverage focus on the EU.
BSI Training Academy – Medical Devices is a premier provider of management systems and organizational resilience training, offering expert-led courses across various industries. They are dedicated to shaping society by developing a resilient digital future that respects privacy, safety, cybersecurity, and reliability.
**Expertise & scope**
* Expert-led courses in management systems and organizational resilience.
* Focus on developing a resilient digital future, emphasizing privacy, safety, cybersecurity, and reliability.
* Training in standards such as Quality Management 9001, Information Security 27001, Environmental Management 14001, and Occupational Health and Safety Management 45001.
**Reputation / proof points**
* Offers training in Quality Management 9001.
* Offers training in Information Security 27001.
* Offers training in Environmental Management 14001.
* Offers training in Occupational Health and Safety Management 45001.
* Offers training in Carbon Footprint Verification 14064-1.
* Operates globally, with a coverage focus on the EU.
Additional information
BSI Training Academy focuses on empowering organizations through comprehensive training programs designed to enhance management systems and organizational resilience. Their approach emphasizes practical application of standards to foster a culture of trust and build future-ready workforces. Buyers can expect training that addresses critical areas like digital trust, artificial intelligence, and the development of robust internal governance procedures that align with best practices. Engagement typically involves expert-led sessions aimed at improving business performance and navigating complex regulatory landscapes.
Key Highlights
-
Offers expert-led courses in management systems and organizational resilience.
Source
“BSI Training Academy is a premier provider of management systems and organizational resilience training, offering expert-led courses in various industries.”
-
Focuses on developing a resilient digital future, respecting privacy, safety, cybersecurity, and reliability.
Source
“Shaping society by developing a resilient digital future, that respects privacy, safety, cybersecurity, and reliability.”
-
Provides training in key standards including Quality Management 9001 and Information Security 27001.
Source
“Quality Management 9001 Information Security 27001”
Certifications & Trust Signals
-
BSI has a Royal Charter, first awarded in 1929, setting objectives 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.”
-
BSI supports a global community of 13,000 experts.
Source
“We support a 13,000-strong global community of experts”
-
BSI has established internal governance procedures that reflect best practice.
Source
“established internal governance procedures that reflect best practice”
Buyer Snapshot
Best for
- Organizations seeking to improve management systems.
- Companies focused on organizational resilience.
- Businesses needing training in international standards.
How engagement typically works
- Expert-led training courses.
- Focus on practical application of standards.
Typical deliverables
- Certified training programs.
- Enhanced understanding of management systems.
- Improved organizational resilience.
Good to know
- Best when organizations are looking for structured training to meet compliance and operational excellence goals.
HQ:
Reston, United States
Languages:
English
Timezones:
Europe/Brussels
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
No specific onboarding steps for EUDAMED registration support were found. The website content focuses on general training and organizational standards.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Supports Actor Registration
No
Supports UDI
No
Supports Vigilance
No
Supports Clinical Investigations
No
