Successfully Supporting EU MDR Implementation for Medtronic

A Regulatory Compliance and Supplier Quality Project | May 2019 – May 2020 | TCS Noida

From May 2019 to May 2020, I had the opportunity to work on a critical and high-impact project supporting Smith Medical—now part of Medtronic—as they prepared for compliance with the European Union Medical Device Regulation (EU MDR 2017/745). This new regulation, which officially replaced the Medical Device Directive (MDD), brought significant changes to how medical devices were classified, validated, documented, and monitored in the European market.

Working through Tata Consultancy Services (TCS) from its Noida location, I was deployed as part of the quality and regulatory consulting team.

My key responsibilities focused on technical file remediation, supplier development, and Production Part Approval Process (PPAP) alignment, ensuring that Smith Medical’s devices were ready to meet the stringent expectations of the new regulation, well ahead of the enforcement deadline. This blog post outlines the scope of the project, the challenges we addressed, and how our quality and supplier assurance efforts contributed to a successful regulatory transition.

Project Context: What Made EU MDR So Challenging?

EU MDR was not just a revision of older regulatory frameworks—it was a complete overhaul of how medical devices were evaluated, documented, and tracked throughout their lifecycle. Among its key new requirements were: Expanded product classification rules (especially affecting software and reusable devices)

Detailed clinical evaluation and post-market surveillance (PMS) requirements

Mandatory UDI (Unique Device Identification) implementation

Greater scrutiny of supplier and component-level documentation

Stronger emphasis on risk management and process validation.

For Medtronic, whose product portfolio included Class II and Class III devices such as infusion pumps, catheters, and critical care accessories, the transition to EU MDR required a cross-functional, global effort involving engineering, regulatory affairs, quality assurance, and supplier management.

My Role: Bridging Quality, Compliance, and Supplier Readiness

As part of TCS’s Quality Engineering and Regulatory Practice group, I was responsible for three main streams within the EU MDR project:

• Supporting technical documentation remediation

• Developing and qualifying critical suppliers

• Aligning supplier PPAP submissions with EU MDR expectations

Here’s a breakdown of the contributions I made across each area.

1. Technical File Remediation and Process Validation

   I worked closely with the internal regulatory and engineering teams to review and update Design History Files (DHF), Device Master Records (DMR), and risk management documentation. My focus was primarily on reviewing:

   Process validation records (IQ/OQ/PQ)

   Inspection reports and test protocols

   Design control traceability

   Component-level verification linked to supplier inputs

In many cases, legacy validation documents were found to be either insufficient or missing key evidence under the new MDR clauses. I conducted gap assessments on these files, drafted supplemental rationales, and coordinated revalidation activities with the manufacturing team. For example, one critical supplier's moulded component lacked robust process capability data, triggering a fresh OQ and PQ exercise, which I helped plan and review remotely.

2. Supplier Development and Audits

A major part of the EU MDR implementation involved validating the quality systems and documentation of external suppliers, especially for high-risk and Class III product components. My role included:

Coordinating supplier audits, focusing on their process validation, traceability, and document control practices

Reviewing Supplier Quality Agreements (SQAs) to ensure that roles and responsibilities under MDR were clearly defined

Creating Supplier Risk Ranking Matrices to prioritise engagement based on component criticality and supplier compliance history

Supporting updates to supplier-controlled documents, including drawings, process flows, and Certificates of Conformance (CoCs)

I worked directly with both domestic and international suppliers, ensuring that they understood the regulatory impact of EU MDR and had clear action plans to address gaps.

One of the key value-adds was creating supplier training material tailored to MDR Article 10 and Annex II requirements. I helped deliver virtual sessions on documentation expectations, traceability, and post-market data responsibilities.

3. PPAP Implementation for Medical Device Components.

As a Six Sigma Black Belt with a background in automotive and regulated industries, I had prior experience with the Production Part Approval Process (PPAP) a methodology traditionally associated with the automotive sector, but increasingly adopted in the medical device industry for supplier qualification.

Smith Medical saw an opportunity to formalise and standardise PPAP documentation for high-risk and new components as part of MDR readiness.

My tasks included:

• Creating and reviewing PPAP elements such as Process Flow Diagrams, PFMEAs, Control Plans, and MSA studies

• Ensuring that First Article Inspections (FAI) aligned with EU MDR traceability and UDI requirements

• Supporting the creation of Part Submission Warrants (PSWs) to serve as sign-offs for supplier readiness

• Integrating PPAP packages into the company’s eQMS and linking them with device-level technical files

• The result was a cleaner, more audit-ready documentation trail for critical parts reducing the risk of non-compliance during Notified Body audits.

• Project Outcomes and Impact

• Over the course of the 12-month project, our team supported the MDR readiness of over 60 product families and 35 critical suppliers. 

  
  

Key outcomes included:

Successful Notified Body feedback for submitted technical files without major findings

Completion of process re-validations for high-risk device lines

Implementation of supplier PPAP documentation for key components

Establishment of a supplier monitoring dashboard to track audit outcomes, risk scores, and CAPA progress

From a regulatory standpoint, the project gave Smith Medical the confidence to maintain uninterrupted market access in the EU. From a quality perspective, it led to stronger documentation integrity, clearer supplier accountability, and smoother collaboration across global teams.

Lessons Learned and Reflections

Working on the EU MDR project with Smith Medical through TCS was not only technically challenging but also deeply rewarding. It sharpened my understanding of how regulatory frameworks drive operational discipline and collaboration across supply chains.

More importantly, it gave me the opportunity to integrate my technical knowledge—process validation, PPAP, risk management with real-world business needs in a high-stakes, compliance-focused environment.

This experience reinforced my belief in quality as a proactive function—one that enables innovation, ensures patient safety, and adds long-term value across the product lifecycle.

Conclusion

As regulatory expectations continue to evolve globally, the role of quality professionals with cross-domain expertise in systems like PPAP, supplier development, and risk-based decision-making will only grow more critical. This project remains one of the most impactful chapters in my professional journey, and I’m proud to have contributed to it.

For those pursuing a career in quality engineering or medical device compliance, I hope this project overview offers insights into how technical rigour, regulatory understanding, and effective collaboration come together to deliver results.

Feel free to connect with me if you’re working on similar challenges or are exploring a career in this field.