Background

A company that created a Pulse Oximeter (SpO2) intended for adult patients in a home environment for passive, non-invasive, intermittent data collection of physiological parameters was looking to receive marketing authorization in Australia, Brazil, Japan, Canada, and the US. 

Challenge

The Client was in need of a global medical device compliance partner to evaluate existing systems and make recommendations on what needs to be done for entering the target markets. 

Solution

Elexes advised that for getting to all the target countries, the Client will have to obtain regulatory approvals from the corresponding regulatory bodies, while for the quality systems, the Client should pursue an MDSAP. 

Elexes provided a thorough understanding of harmonization of MDSAP across the 5 countries, and helped the Client find the right Notified Body (NB) who can audit and issue an MDSAP certification timely. 

The primary steps adopted by Elexes were as follows: 

• Conduct a gap assessment to identify the gaps in the existing Quality Management System (QMS) 
• Address each of the gaps to make an MDSAP compliant system 
• Conduct an internal audit to assess effectiveness of the updated QMS 
• Conduct an MRM where inputs like the previous MRM action items, internal audit results, complaint trends etc were evaluated 
• Support the company during the MDSAP certification audit and assist with addressing follow up questions or observations 

MDSAP comprises many chapters as shown below.  

When implementing the Chapter 5 of MDSAP, Design and Development, Elexes suggested the importance of ISO 80601-2-61 standard, accuracy, pulse rate performance, and other performance and safety testing requirements for the Pulse Oximeter. Elexes helped establish traceability between design inputs, outputs, testing and risk assessment for a robust Design History File (DHF). 

Results

Elexes’s profoundly capable team supported the company in implementing an MDSAP  compliant QMS in a short period of time. Elexes Team integrated into the Client’s team like their own and guided through every chapter of MDSAP from design to production to post market surveillance. By getting the MDSAP and pursuing regulatory approvals, the company could successfully launch its product in all the five countries.  

Key Takeaway

When targeting more than one country at a time it is important that medical device companies seek professional help and understand how the harmonization across various countries can be used to one’s advantage, thereby reducing the yearly number of audits and inspections that they undergo for compliance.