Medicaldevicehq

★★★★★ 5.0 / 5
50 reviews

About

Medicaldevicehq provides tailored training solutions to meet specific company needs in the medical device industry. They focus on delivering expert guidance and resources to help organizations navigate complex regulatory landscapes. Their offerings are designed to address critical areas such as design control, quality management, and risk management, ensuring clients can achieve and maintain compliance.

**Who they are**
Medicaldevicehq is a training provider focused on the medical device sector, offering specialized programs to enhance company compliance and operational efficiency.

**Expertise & scope**
- Design control
- Electrical safety
- Project management
- Quality management
- Risk management
- Usability Engineering
- Software development
- Support for standards including IVDR, IEC 60601-1, IEC 62366-1, IEC 82304-1, MDR, and QSR.

**Reputation / proof points**
- Based in Lund, Sweden.

Additional information

Medicaldevicehq offers flexible training plans, including online and online lifetime options, with special launch pricing available. They emphasize tailoring training to the unique requirements of each company. When submitting inquiries via their form, personal data is processed according to their privacy policy. The company supports a wide range of industry standards and topics crucial for medical device compliance.

Key Highlights

  • Offers training on key medical device topics including Design Control, Quality Management, and Risk Management. Source
    “Design control Electrical safety Project management Quality management Risk management Usability Engineering Software development”
  • Supports compliance with major industry standards such as IVDR, MDR, and IEC 60601-1. Source
    “IVDR IEC 60601-1 IEC 62366-1 IEC 82304-1 MDR QSR”
  • Provides tailored training solutions to meet specific company needs. Source
    “TAILORED TRAINING TO MEET YOUR COMPANY’S NEEDS​”

Certifications & Trust Signals

  • Located in Lund, Sweden. Source
    “Location: Lund, Sweden”

Buyer Snapshot

Best for
  • Medical device companies seeking specialized compliance training
  • Organizations needing to understand and implement specific industry standards
How engagement typically works
  • Tailored training programs
  • Online learning options
Typical deliverables
  • Compliance training modules
  • Guidance on industry standards
  • Support for quality management systems
Good to know
  • Best when specific training needs align with their listed expertise areas.

Pricing

Model: Custom pricing
Public range: Publicly listed: Special launch offer: €299 for the online plan & €349 for the online lifetime plan.
Notes: Pricing based on special launch offer; standard pricing may vary.
“Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.”
Status: listed

Services & Capabilities

Packaging + Shelf-life + Distribution Testing

Packaging Tests Offered: Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop
Shelf Life Methods Offered: Real-time aging, Accelerated aging
Distribution Tests Offered: Vibration, Drop, Compression, Climate
Standards Supported: ISO 11607, ASTM D4169, ISTA
Is Accredited: Yes
Accreditation Body: ISO 17025
Has Climate Chambers: Yes
Has Distribution Simulation: Yes
Sample Return Policy: Dispose

Additional packaging_shelf_life_testing Details

Standards Supported
IVDR, IEC 60601-1, IEC 62366-1, IEC 82304-1, MDR, QSR
Pricing Model
Fixed package
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