Notable Projects

Management of the remediation of a contact lens 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

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.

Liaising with the manufacturer and their critical suppliers to conduct a process mapping exercise aimed to identify all equipment, control plans, sample sizes, competency strategies, certifications, etc.

Conducted a risk assessment based on the findings of process mapping, control assessments, and identified actions to mitigate risks.

Conducted in-house training on Root Cause Analysis as well as structured problem-solving techniques.

Roles & Responsibilities:

Liaising with manufacturer & suppliers

Extensive Process mapping

Risk assessments

Mitigation of risks

Training on Root Cause Analysis & Problem solving techniques

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.

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 in an IVD organisation.

Regulatory requirements of the organisation demanded total traceability throughout the supply chain as well as ISO 13485 driving the requirements for a risk based and proportional approach to managing suppliers.

The outcomes of the project were a remediated supplier quality system and implementation of a risk-based system, as well as consolidation of a supplier of suppliers to reduce the cost of maintaining the supply chain without compromising compliance or effectiveness of the QMS.

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

Successfully led the quality & regulatory project for implementation of a fresh QMS, as well as remediating legacy technical files to be compliant to current regulatory and reviewer demands.