⚙️ Process and Infrastructure Validation Consulting

Standard-Compliant Verification and Certification of Critical Processes in Medical Devices

Validation of infrastructure and specialized manufacturing processes used in medical device production is a cornerstone of product safety and regulatory compliance. At Era Management, we plan your process validations, prepare protocols, and fully manage reporting processes in accordance with ISO and MDR/FDA requirements.

All tests are conducted in collaboration with accredited laboratories, and we manage the entire preparatory process, including test planning and product selection.

1. Infrastructure Process Validations

Clean Room and Environmental Validation

  • • ISO 14644-1/2: Particle counting and class verification
  • • ISO 17141: Microbial contamination control
  • • Measurements of temperature, humidity, pressure difference, and air exchange rate.
  • • Validation protocol and annual review plans

Sterilization Validation

  • • ISO 11135: EtO, ISO 11137: Gamma, ISO 17665: Moist heat (autoclave)
  • • Sterilization cycle verification, use of biological indicators, loading configuration
  • • Dose calculation, penetration and aeration validation

2. Specific Process Validations

Production Processes

• Plastic injection molding, CNC machining, casting, ultrasonic cleaning, and surface coating validation.

Reusable & Clean

• Reprocessing/cleaning validation (ISO 17664) and sterilization processes for reusable products.

Software and Hardware Processes

• Embedded software validation, process software (ERP, SCADA) validation, and software lifecycle management (SDLC).

3. Test and Laboratory Coordination

Defining testing needs, selecting an accredited laboratory, and configuring test settings for products based on worst-case scenarios.

Process Validation Flow

1️⃣

Process Analysis

🔍 Product, equipment, risk analysis (FMEA, etc.)

2️⃣

Setting Standards

📚 Applicable to ISO / MDR / FDA requirements

3️⃣

The Worst Scenario Choice

⚠️ Representative (worst-case scenario) product selection based on all variations.

4️⃣

Protocol Preparation

📝 Validation plan, approved document structure

5️⃣

Test Planning & Coordination

🔬 Referral to an accredited laboratory, sample submission.

6️⃣

Reporting and Closing

📑 Analysis of test results, results report, and revalidation plan if necessary.

✅ Why Era Management?

  • ✔ Full compliance with ISO 13485, ISO 14971, MDR and FDA requirements.
  • ✔ Worst-case scenario selection and traceability expertise
  • ✔ Transparent business model with impartial, accredited laboratories.
  • ✔ Non-repetitive, “non-uniform” solutions tailored to your process.

📞 Contact Us!

👉 Contact us for a free preliminary validation assessment.

Frequently Asked Questions

We offer professional consulting services in the establishment, integration, and certification processes of international quality, environmental, and occupational health and safety management systems, primarily focusing on medical device standards (ISO 13485) and MDR processes, as well as ISO 9001, ISO 14001, and ISO 45001.

Our processes begin with a situation analysis (GAP) where we examine your company's current structure. This is followed by an end-to-end process that includes establishing a company-specific documentation structure, integrating processes, conducting internal audits, and preparing for certification audits.

The length of the process varies depending on the scope of the chosen standard, the company's existing infrastructure, the number of employees, and the complexity of the processes. Generally, the preparation and audit processes are completed within 2 to 4 months.

Yes, we are also here to support you in ensuring the continuity of the system after certification, providing internal audit support, and preparing for annual surveillance audits.

We adhere to professional confidentiality principles in all our operations. Your company's technical and commercial information is protected under mutually signed confidentiality agreements.

Get More Information

For details about our management systems processes and corporate consulting services, please contact us.

+90 (216) 376 66 21

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