Case studies
Medical Devices
EU MDR and DHF remediation projects delivered for global medical device manufacturers.
Case study 01
EU MDR remediation for Class IIa devices
Evaluation of technical files and DHFs against EU MDR 2017/745 with supporting risk management activity.
Scope
Evaluate technical files and DHFs for compliance to EU MDR 2017/745 for Class IIa devices — surgical knives, blades and cannulas — with risk management support per ISO 14971:2019.
Customer
A global medical device company and market leader in developing ophthalmic devices, offering a broad range of accessories and single-use instruments for surgeons across the globe.
Solution
01
Design & Development Plan
Create and update the design and development plan for the products in scope.
02
Requirements
User needs, design input requirements and DIOVV (Input,Output,Verification,Validation) matrix for identified requirements.
03
Risk Management
GAP assessment for ISO 14971:2019, Creation and updation of Risk managment plan and report , Harzard Analysis, Benefit RIsk Analysis, DFMEA, PFMEA
04
Usability & Validation
Task analysis and usability file per EN 62366; gap summary for IQ, OQ and PQ.
Key highlights
GSPR Checklist
Created the GSPR checklist and introduced it to the client.
Gap Assessment
EU MDR 2017/745, ISO 14971:2019, ISO 13485:2016, ISO 14644 and EN 62366.
Automation
Created a macro tool to auto‑populate failure modes across manufacturing processes, streamlining workflows and cutting effort by 40%.
Team Size
5
Duration
6 Months
Tools Used
MS Word, Excel
Engagement
Offshore T&M
Case study 02
DHF remediation across 21 product families
Design History File remediation to comply with FDA regulation 21 CFR 820.30 for Class II devices.
Scope
DHF remediation to comply with FDA regulation 21 CFR 820.30 for 21 product families. Device type: Class II.
Customer
A global medical device company that develops and markets orthopaedic implant devices, surgical instruments and a platform of smart technologies for hospitals and physicians.
Solution
01
Gap Analysis
Perform gap analysis in the Design Traceability Matrix and remediate with SME review.
02
Verification Reports
Drawing, label and tolerance analysis reports for design inputs identified in the DTM.
03
Tolerance Analysis
Theoretical and CAD-based tolerance analysis in MMC condition.
04
CAD & Release
Update existing drawings in NX and release documents in Teamcenter.
Key highlights
21
Product families
Remediated across the programme.
11
Team members
6 onsite and 5 offshore.
4
Outputs
Drawing verification, DTM, label verification and tolerance analysis.
Swift Ramp‑Up Capability
Built a 12‑member engineering team in just 3 weeks, ensuring swift ramp‑up and delivery readiness.
Team Size
11
Duration
13 Months
Tools Used
Teamcenter & NX
Engagement
Offshore & Onsite
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