Case Studies

Starting Point & Objective

A medical device manufacturer approached SIFo Medical to support implementing a compliant design control process.

The goal was to develop a new medical device in line with ISO 13485:2016 and FDA’s 21 CFR 820.30 requirements. While the client had initial design input requirements, a structured and audit-ready technical documentation system was missing.

Our Approach to Design Control Implementation

1. Structured Design Control Process

We guided the client through the entire development process with a clear design and development plan, including:

• Project planning with defined development phases, milestones, and review gates.
• Design and development activities aligned with ISO 13485 and FDA requirements.
• Design reviews, risk management (according to ISO 14971), and traceability implementation.

2. Consolidating and Translating Design Inputs

Together with the client and key suppliers, we translated design inputs into technical specifications:

• Development of drawings, bill of materials (BOMs), and material specifications.
• Definition of critical-to-quality characteristics (CTQs) and process requirements.

3. Design Outputs & Technical Documentation

Based on these inputs, we systematically created and documented the relevant outputs:

• Detailed product and process descriptions
• Integration into a complete technical documentation package for CE and FDA submissions
• Establishment of a full Design History File (DHF)

4. Verification & Validation (V&V)

A critical part of the project was the planning and execution of verification and validation activities:

• Creation of verification plans, including test methods and sampling strategies.
• Testing conducted both in-house and at accredited laboratories:
  • Biocompatibility testing (ISO 10993)
    • Electrical safety testing (IEC 60601)
      • Test Method Validation to ensure objective, reproducible results

All outcomes were documented in line with Good Documentation Practice (GDP).

Challenges & Solutions

Challenge:  Fragmented design inputs from multiple sources.

Solution:  Standardized templates for specifications, a traceability matrix, and structured reviews.

Challenge:  Parallel coordination of internal and external stakeholders.

Solution:  Clear responsibility assignments and an integrated project plan with regular status reviews.

Project Outcomes

The project resulted in a complete, MDR- and FDA-compliant development file. A structured and standards-based approach efficiently met regulatory requirements, and costly rework was avoided. The client now has:

• A fully developed Design History File (DHF)
• Verified, traceable design elements – from user need to verification
• A robust foundation for regulatory submissions (EU & US)

Conclusion

This case study demonstrates what effective design control looks like in medical device development – from the first idea to technical specifications and verification. Thanks to our structured and collaborative approach, the client successfully fulfilled all relevant  ISO 13485 and 21 CFR 820.30 requirements.

Do you need support with design control or technical documentation?

We support medical device manufacturers in implementing regulatory-compliant development processes. 

Initial Situation at Project Start

When entering the project, it became clear that our client had significant gaps across essential QA processes:

1. Manufacturing and Test Processes

• Numerous different processes and test methods – none of them qualified or validated.
• No structured test method development, especially for visual inspections.

2. Process Validation

Process validations were superficial and non-compliant:

• No statistically justified sample sizes.
• OQ studies without defined parameters.
• Missing risk-based logic.
• Additional corporate requirement: alignment with the corporation’s validated standards, which were significantly more stringent than our client's local processes.

3. Equipment Qualification & Calibration

A large equipment inventory was unqualified or insufficiently qualified:

• Ovens and climate chambers without temperature distribution studies.
• Microscopes and endoscopes without qualification.
• Numerous measurement devices not calibrated.
• Many test processes relied on equipment whose condition or performance was not demonstrated.

4. Visual Inspections

Widely used, but:

• Operators not qualified (no vision testing or capability evidence).
• Acceptance criteria not defined.
• Methods neither developed nor validated per applicable standards.
• This was both an FDA finding and a key focus point of the corporate post-merger integration.

5. Multi-Site Challenge (USA & Germany)

Our client operates sites in the U.S. and Germany.
Goal: establish consistent standards so all processes comply with:

• FDA
• ISO 13485
• MDSAP
• Corporate SOPs

Role of SIFo Medical

SIFo Medical was brought in to stabilize the situation and rapidly achieve compliance and corporate alignment.

1. Team Setup & Scaling

• A team of approximately 15 experts was assembled within few weeks.
• Flexible scale-up and scale-down depending on project phases and FDA deadlines.

2. Technical Focus Areas

• Test Method Validation (TMV)
• Process Validation (PV)
• Equipment Qualification (EQ)
• SOP development & process harmonization
• Coaching and training of employees

3. Building a Compliant Quality Framework

SIFo Medical took over the developing or revising all relevant SOPs for:

• Process Validation
• Test Method Validation
• Equipment Qualification
• SOPs were built to ensure full compliance with:
  • FDA
  • ISO 13485
  • MDSAP
  • Corporate standards of the acquiring company

4. Operational Execution

• Execution of complete TMV, PV, and EQ projects.
• Full program leadership for all validation and qualification activities.
• Establishment of robust, reproducible validation strategies (sampling justification, OQ/PQ design, worst-case rationale, etc.).
• Operator qualification – including vision testing and visual inspection requirements.

5. Training & Change Management

• Intensive training sessions at U.S. and German sites.
• Ensured that the new SOPs were not only written but fully understood and implemented in day-to-day operations.

Project Outcome

• Total duration of the project: approx. 2.5 years.
• FDA-related risks were systematically addressed and minimized.
• Corporate requirements were fully implemented.
• QA processes were harmonized and professionalized across all sites.

According to the client, the company "has never worked with freelancers as competent as the team from SIFo Medical." The project is regarded internally and externally as a benchmark for efficiency, compliance, and strategic execution.

Why Packaging Validation Matters

Packaging validation is essential to ensure that sterile barrier systems maintain integrity during manufacturing, transport, storage, and clinical use. With increasing regulatory scrutiny under the MDR, a robust, risk-based packaging validation strategy is more important than ever.

Our Approach to MDR-Compliant Packaging Validation

1. Product Categorization & Risk-Based Planning

We began by classifying all relevant products into logical packaging categories based on material type, size, and sterilization method. For each group, we developed a tailored, risk-based validation plan. Critical products were selected as worst-case representatives, ensuring compliance without unnecessary testing overhead.

2. Statistically Justified Sample Sizes (ISO 16269-6)

To define appropriate sample sizes, we used ISO 16269-6. This allowed us to base our test plans on real process data and variability. Our methodology included:

• Confidence interval estimation
• Tolerance intervals to account for outliers
• Test reduction strategies for proven process stability

3. Comprehensive Testing & Validation Activities

For each packaging category, we executed a structured series of validation steps, including:

• IQ, OQ, PQ  for heat sealing equipment.
• Test method validations such as:
  • Bubble leak test, dye penetration test, peel strength (ASTM F88, F2096, etc.)
• Accelerated aging studies following ASTM F1980 using the Arrhenius model
• Transport simulation tests based on ISTA 1A/2A/3A and ASTM D4169
  • Including drop tests, vibration, compression, and environmental simulations

4. Documentation & Collaboration

All validation steps were fully documented in accordance with Good Documentation Practice (GDP). We collaborated closely with the client and certified external laboratories to ensure both technical accuracy and regulatory compliance.

Results at a Glance

• Proven packaging integrity throughout the entire product lifecycle.
• Efficient resource use through representative product selection.
• Reduced testing effort via intelligent product grouping and risk stratification.
• Transparent, data-driven decisions with traceable documentation.
• Fully compliant with ISO 11607 and MDR requirements.

Conclusion

This project with Dr. Ausbüttel / Draco illustrates how packaging validation can be executed efficiently, without compromising compliance or patient safety. By combining international standards, testing, and risk-based planning, we delivered a sustainable validation solution for a broad product portfolio.

Are you looking for MDR-compliant packaging validation support?

We help medical device manufacturers meet ISO 11607 requirements with tailored, efficient solutions.

Starting Point & Objective

Our client, a European medical device manufacturer, faced serious quality and compliance issues with a key supplier in Asia. A recent audit had revealed multiple critical deviations, triggering immediate action. The objective was to identify root causes on-site, remediate quality system gaps, and validate the manufacturing processes – in full compliance with ISO 13485 and MDR 2017/745.

Our Approach to Process Validation & Quality System Remediation

1. On-site Assessment & Gap Analysis

We conducted an in-depth assessment at the supplier’s facility to evaluate compliance gaps and performance issues.

Key areas of concern included:

• Missing or ineffective quality management processes
• Unqualified clean rooms and manufacturing equipment
• Lack of validated manufacturing and measurement processes

2. Strategic Remediation & Qualification Activities

Based on our findings, we implemented a tailored remediation plan:

• Hygiene management system: Design and rollout of a GMP-compliant hygiene concept
• Clean room qualification: Per ISO 14644 standards
• Measurement method development & validation:
  • Geometric measurement of injection-molded parts
  • Force measurement for welded components
  • Optical evaluation of assembly features

• Process validation:
  • Injection molding of 12 components (up to 8 cavities per mold)
  • Ultrasonic welding of complex assemblies
• Introduction of:
  • A structured change & deviation management system
  • A hygiene monitoring ring for routine oversight

3. Transparent Communication & Collaboration

Throughout the engagement, we kept the client closely informed via weekly progress calls. This ensured transparency, aligned expectations, and helped foster trust across all stakeholders. We used proven tools and methodologies such as Six Sigma to analyze root causes, optimize processes, and ensure statistically sound validation outcomes.

Challenges & Solutions:

Challenge: Significant cultural and language barriers impacting supplier communication.

Solution: On-site presence, bilingual experts, and culturally adapted training methods.

Challenge: Non-existent documentation of critical processes.

Solution: Creation of audit-proof process validation protocols and test method justifications.

Challenge: Lack of measurement capability for process outputs.

Solution: Custom development of measurement systems with Gage R&R validation.

Project Outcomes:

• 60 % reduction in complaint rate due to improved process control aligned with MDR and ISO 13485.
• All audit deviations closed within 12 months.
• Audit-proof documentation.
• Strengthened supplier relationship based on mutual understanding and trust.

Conclusion

This project demonstrates how process validation – when embedded in a broader quality remediation strategy – can transform even critical supplier risks into operational strengths. With clear structure, validated methods, and a collaborative mindset, our client now benefits from a compliant, reliable, and efficient supplier in Asia.

Do you need support with process validation or supplier remediation?We help MedTech companies ensure compliance and performance across their supply chain.

Starting Point & Objective

A medical device manufacturer contacted us urgently after an audit finding revealed missing test method validations (TMV) in their quality system. The audit report highlighted a compliance gap regarding ISO 13485 and FDA 21 CFR 820.80 requirements for validated inspection, measuring, and test equipment. The objective was clear: Quickly establish compliant TMVs for critical product tests, with minimal disruption and maximum regulatory confidence.

Our Approach to Fast & Effective Test Method Validation

1. Immediate Access to the TMV Online Guide

To provide rapid support, we gave the client direct access to our TMV Online Guide, which includes:

• Pre-validated templates for test method validation protocols and reports
• Checklists aligned with ISO 13485 and FDA requirements
• Step-by-step video instructions for correct application
• Guidance documents for understanding Gage R&R, accuracy, repeatability, and more

The client only needed to fill in their specific test data – all structure, wording, and regulatory alignment was already taken care of.

2. Personal Expert Support

In parallel, we supported the client with targeted consulting to answer open questions and review their draft documentation.

Thanks to our efficient format and hands-on experience, we helped the team:

• Select the appropriate validation method
• Define acceptance criteria
• Justify sample sizes and test design
• Understand how to interpret and document the results

Challenges & Solutions

Challenge: Time pressure due to an upcoming follow-up audit
Solution: Instant access to ready-made templates, eliminating delays caused by blank-page syndrome

Challenge: Lack of internal expertise on TMV requirements
Solution: Step-by-step video explanations and expert Q&A support for each stage

Challenge: Concern about audit acceptance.

Solution: Templates and validation logic aligned with ISO 13485, FDA 21 CFR 820, and GHTF guidelines – ensuring audit-proof documentation.

Project Outcomes

• Full TMV package completed within days.
• Audit deviation closed successfully and sustainably.
• Compliant and traceable validation of critical test methods.
• Improved internal know-how for future validations.

Conclusion

This case demonstrates how fast and effective Test Method Validation can be – when the right tools and expert guidance are in place. Our TMV Guides enabled the client to meet regulatory requirements, close an audit finding, and build a robust validation framework in record time.

Starting Point & Objective

elm-plastic GmbH, a medical device manufacturer, approached us with a clear challenge: justifying the sample sizes used in their process validation. Since sample sizes are derived from risk management, we first needed to implement a strong risk management system. This system was designed to comply with ISO 14971 and other relevant regulations, while also improving internal processes for greater efficiency.

Our Approach to Risk Management Optimization

Comprehensive Assessment

We began with a thorough evaluation of elm-plastic GmbH's existing risk management framework, identifying areas for improvement and ensuring alignment with current regulatory requirements.

Customized Risk Management Framework

Based on our assessment, we developed a tailored risk management framework that integrates seamlessly with their existing quality management system. This included:

• Development of risk management procedures and templates compliant with ISO 14971.

• Training sessions for key personnel to ensure proper implementation and understanding of the new processes.

• Integration of risk management activities into the product development lifecycle.

Ongoing Support and Consultation

Throughout the implementation process, we provided continuous support and consultation to address any challenges and ensure the successful adoption of the new risk management system.

Challenges & Solutions

Challenge: Aligning existing processes with updated regulatory requirements.

Solution: We provided a clear roadmap and practical tools to bridge the gap between current practices and regulatory expectations, facilitating a smooth transition.

Challenge: Ensuring staff engagement and understanding of new risk management procedures.

Solution: Conducted interactive training sessions and provided user-friendly documentation to promote comprehension and buy-in from all stakeholders.

Project Outcomes

• Enhanced Compliance: elm-plastic GmbH's risk management processes are now fully aligned with ISO 14971 and other relevant regulations.
• Improved Efficiency: Streamlined processes have reduced redundancy and improved overall operational efficiency.
• Empowered Team: Staff are better equipped with the knowledge and tools necessary to manage risks effectively.

Conclusion

This collaboration between elm-plastic GmbH and SIFo Medical demonstrates the value of a structured and customized approach to risk management in the medical device industry. By focusing on compliance and efficiency, we helped elm-plastic GmbH enhance their risk management processes, ensuring better outcomes for both the company and the patients they serve.