Our team lead and project managed the remediation of a contact lense organisation who experienced being brought into scope of MDR under Annex XVI.

The organisation had never previously undertook a Quality Management System implementation to work to the stringency of the medical device standards and regulations such as ISO 13485, REGULATION (EU) 2017/745 & 21 CFR Part 820 Quality System Requirements.

Roles & Responsibilities:

Lead Project Management

ISO 13485 Implementation

Regulatory Pathway Planning into USA & Europe

Clinical Evaluation

Supplier Management

This global client found itself in a position of difficulty when their CAPA procedure was overbearing and as a result was bringing non-significant issues into the scope of the CAPA process.

This had several associated risks, namely that the CAPA process was not being used to manage systemic and significant issues within the Quality System.

Roles & Responsibilities

CAPA Remediation Project Lead

Stakeholder management

CAPA Procedure Development

Remediation and consolidation of overdue CAPAs

Another global client that had an embargo placed upon them by the Food & Drugs Administration (FDA).

The quality management system had to be brought up to speed to meet the requirements of 21 CFR part 820. This required a huge remediation effort, of which The Other Consultants played a leading role within.

Roles & Responsibilities:

Lead Project Management

ISO 13485 Implementation

Regulatory Pathway Planning into USA & Europe

Supplier Management

The Other Consultants were engaged to implement a risk-based supply management methodology

Working with a global contact lens manufacturer, who had identified the need for increased visibility of the quality management principles being applied by their critical suppliers of Class IIa and IIb Medical Devices.

The Other Consultants worked with the manufacturer and their critical suppliers to first conduct a process mapping exercise this identified all equipment, control plans, sample sizes, competency strategies, certifications and much more related to the process.

Following this, The Other Consultants together with the manufacturer conducted a risk assessment based on the findings of process mapping, control assessments, and identified actions to mitigate risks.

The Other Consultants also conducted in-house training on Root Cause Analysis as well as structured problem-solving techniques with these.

A medical device manufacturer of a number of products covering a span of Class I - IIb had critical findings raised by their notified body.

The Other Consultants were engaged as a QARA consultant to assist in liaising with the notified body on corrective action plans, defining and implementing the required corrective actons across the entire QMS.