Hello, I’m Adam, and I’m a medical device quality and regulatory consultant.
I provide medical device consulting services to companies on quality and regulatory matters.
I take pride in becoming trusted partner delivering pragmatic and risk-based advice to enable organisations place safe and effective devices on the market, while considering their business goals. Regulatory consultancies must be mindful of the cost of compliance we create for manufacturers, and that remains one of my core values.
I’ve worked in the industry for 10 years - how time flies when you're having fun…
I work as a medical device consultant, but I'm also a qualified lead auditor who works with certification bodies. This gives me a unique view to understand the perspective of both sides of the table - the auditor and the auditee.
I strive to create genuine, human connections within the medical device manufacturing community.
As a regulatory consultant for medical devices, it’s my role to put medical device organisations in safe hands when dealing with quality and regulatory matters.
Notable Projects
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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
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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
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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
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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
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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.
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