Comply Guru (EU MDR Requirements Training)
Comply Guru
Comply Guru offers globally recognized, flexible training for ISO Standards, Auditing, and Medical Device Regulations, including EU MDR and FDA QMSR. Trusted by leading organizations and Notified Bodies.
Comply Guru specializes in transformational training for MedTech QA/RA, simplifying complex international standards and regulations. They offer globally recognized credentials in various formats (online, face-to-face, blended) for ISO 13485, ISO 9001, EU MDR, EU IVDR, MDSAP, FDA QMSR, and more. Founded in 2019 to address the need for accessible and flexible learning solutions, Comply Guru is trusted by Competent Authorities, Notified Bodies, Registrars, Consultants, and Global Brands. Their mission is to make essential training more dynamic, scalable, and convenient for the modern workforce. Comply Guru is committed to GDPR compliance in its data processing for learner administration and educational obligations.
About
**Who they are**
Comply Guru (EU MDR Requirements Training) was launched in 2019 as an Approved Training Provider specializing in innovative learning methodologies for international standards and regulations. Their mission is to simplify the complex landscape of these requirements.
**Expertise & scope**
* Globally recognized, flexible training for ISO Standards, Auditing, and Medical Device Regulations.
* Specific expertise in EU MDR, FDA QMSR, ISO 13485, ISO 14971, EU IVDR, MDSAP, CAPA, and Quality Management (ISO 9001).
* Training covers requirements, PRRC, Clinical Evaluation, PMS, Auditor Skills, and Advanced Practitioner levels.
* Learning methodologies are available in online, face-to-face, or blended formats.
**Reputation / proof points**
* Founded in 2019.
* Training has been delivered globally.
* Trusted by leading organizations and Notified Bodies.
* First learning provider globally to achieve multi-certifications for their learning methodologies.
Comply Guru (EU MDR Requirements Training) was launched in 2019 as an Approved Training Provider specializing in innovative learning methodologies for international standards and regulations. Their mission is to simplify the complex landscape of these requirements.
**Expertise & scope**
* Globally recognized, flexible training for ISO Standards, Auditing, and Medical Device Regulations.
* Specific expertise in EU MDR, FDA QMSR, ISO 13485, ISO 14971, EU IVDR, MDSAP, CAPA, and Quality Management (ISO 9001).
* Training covers requirements, PRRC, Clinical Evaluation, PMS, Auditor Skills, and Advanced Practitioner levels.
* Learning methodologies are available in online, face-to-face, or blended formats.
**Reputation / proof points**
* Founded in 2019.
* Training has been delivered globally.
* Trusted by leading organizations and Notified Bodies.
* First learning provider globally to achieve multi-certifications for their learning methodologies.
Additional information
Comply Guru focuses on transforming training delivery to be more dynamic, flexible, and convenient for professionals managing busy schedules. They offer a range of learning formats including online, face-to-face, and blended options to accommodate diverse learning preferences and accessibility needs. Their specialized training addresses critical areas within medical device regulations and quality management systems, equipping individuals with practical skills and knowledge required for compliance.
Key Highlights
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Specializes in training for EU MDR Requirements, PRRC, Clinical Evaluation, PMS, and Auditor Skills.
Source
“EU MDR Requirements, PRRC, Clinical Evaluation, PMS and Auditor Skills”
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Offers training for FDA QMSR requirements.
Source
“FDA QMSR New FDA QMSR Requirements for Practitioners”
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Provides training for ISO 13485, including Requirements, Internal Auditor and Lead Auditor.
Source
“ISO 13485 Requirements, Internal Auditor and Lead Auditor”
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Training is available in online, face-to-face, or blended formats.
Source
“Whether it is an online, face to face, or blended format, we have it covered.”
Certifications & Trust Signals
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Trusted by leading organizations and Notified Bodies.
Source
“our training has been delivered globally and is trusted by both Leading Organizations in Industry & Notified Bodies.”
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The first learning provider globally to achieve multi-certifications for their learning methodologies.
Source
“Comply Guru has the distinction of being the first learning provider in the world to achieve multi-certifications for our learning methodologies in the industries we serve.”
Buyer Snapshot
Best for
- Organizations seeking specialized training in medical device regulations (EU MDR, FDA QMSR)
- Professionals needing flexible learning options for ISO standards and auditing
- Companies and individuals requiring training on quality management systems
How engagement typically works
- Online, face-to-face, and blended training formats
- Focus on practical skills and requirements
Typical deliverables
- Training courses on EU MDR, FDA QMSR, ISO 13485, ISO 14971, etc.
- Certifications for learning methodologies
- Skills development in auditing, requirements, and specific regulatory areas
Good to know
- Best when buyers require flexible and accessible training solutions.
HQ:
Limerick, Ireland
Languages:
English
Timezones:
America/Los_Angeles
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU
Countries:
US, DE, FR, GB
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
6-25, 26-100
Onboarding time:
3–17 days
Pricing model:
Per project
Starting from:
USD 400
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
Yes
Supports IVDR
Yes
Onboarding Steps
Contact Comply Guru to discuss needs and set up a call.
Verification Support
No
Storage Conditions Support
No
