October, 2025 | RAC Forge

Sterilization Validation for Medical Devices

21 Oct

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Sterilization Validation for Medical Devices

Sterilization validation is essential for sterile medical devices. Understanding sterilization methods and validation requirements is crucial

Biocompatibility Testing Strategies for Medical Devices

11 Oct

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Biocompatibility Testing Strategies for Medical Devices

Biocompatibility assessment, or Biological Evaluation, is a key Essential Requirement for medical device regulatory approval. Knowing ISO 10993 standards and

Mastering EU MDR Technical Documentation

10 Oct

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Mastering EU MDR Technical Documentation

The European Union’s EU MDR (Medical Device Regulation 2017/745) sets strict rules for technical documentation. Knowing these

Navigating USFDA’s 510(k) Submission Process

10 Oct

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Navigating USFDA’s 510(k) Submission Process

The 510(k) USFDA premarket notification is the most common pathway for Class II medical devices seeking USFDA clearance. Knowing this process

Understanding CDSCO’s Medical Devices Rules, 2017

10 Oct

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Understanding CDSCO’s Medical Devices Rules, 2017

The Indian MDR (Medical Devices Rules, 2017) set by India’s Central Drugs Standard Control Organization (CDSCO) create

Sterilization Validation for Medical Devices

Biocompatibility Testing Strategies for Medical Devices

Mastering EU MDR Technical Documentation

Navigating USFDA’s 510(k) Submission Process

Understanding CDSCO’s Medical Devices Rules, 2017

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Sterilization Validation for Medical Devices

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Mastering EU MDR Technical Documentation

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