Case Study 13: Medical Device Manufacturer Audit for a Spanish Client
Client: A Spanish medical device company specializing in diagnostic kits
Challenge:
The client required a detailed audit of a medical device manufacturer in India to ensure compliance with ISO 13485 and EU MDR standards. Timely qualification was critical for a new product launch in Europe.
Solution by Qualifyo:
- Conducted a thorough documentation review followed by a two-day on-site audit.
- Assessed the supplier’s QMS, risk management system, and product traceability processes.
- Identified gaps in the supplier’s internal audits and provided recommendations to align with ISO 13485.
Outcome:
- The supplier implemented Qualifyo’s recommendations and passed a notified body audit within 60 days.
- The client successfully launched their diagnostic kits in Europe, meeting the market timeline.
- Qualifyo’s services reduced the client’s audit costs by 25% while ensuring compliance.
