Triskele Consulting Limited
Your Engineering, Quality and Regulatory Partner for new and growing Medical Device companies.
Triskele Consulting provides design & development, quality systems/compliance and regulatory support to both new and established medical device companies. With niche expertise in active devices, active implantable devices, implantable and invasive devices combined with specialist knowledge of the related sterilization requirements, Triskele Consulting develops and delivers the strategy to get your product to market and maintain its compliance in the increasingly regulated medical device environment.
With 25 years of industry experience built upon the foundations of engineering, quality and regulatory qualifications and continuing professional development, Triskele Consulting provides hands-on practical solutions as an embedded member of your team.
Create. Comply. Change.
It is never too soon to discuss the regulatory strategy option(s) needed to bring that great idea to the market – especially when that strategy may be different from country to country. Plan early about what it will mean to implement a quality management system and when is the right time for your project. Quality management systems bring structure to the product development process; when implemented correctly, they deliver both the space to be creative but efficiency in how product testing is planned, when to perform risk management through verification and validation while producing all the records you will need to meet your regulatory needs.
Triskele Consulting can spend as little or as much time with you in the early stages while you are CREATING great product concepts. If nothing else, we’ll advise on what you’ll need to do from a regulatory approval perspective and make sure you don’t end up repeating unnecessary stages and get the documentation right from the feasibility stages onwards.
Sooner or later (sooner is better!), you will need to implement a Quality Management System (QMS). Triskele Consulting Ltd has experience in delivering new and bespoke Quality Management Systems built from the ground up to meet the requirements of EN ISO 13485 (European Union) and 21 CFR 820 (USA). We can provide you with a QMS package with the required procedural templates to demonstrate that you COMPLY with the applicable regulations to deliver QMS certification- usually a pre-requisite to regulatory approvals.
Most new start-ups have limited resources and can’t justify a full-time QA/RA internal role. As needed, Triskele Consulting provides dedicated quality leadership (including Management Representative function), quality support, independent reviews, supplier and internal audits on a flexible basis. We can manage the relationship and interactions with your notified body and other regulators to manage your external audits and regulatory submissions.
Products and quality systems are dynamic – constantly changing to be better. Changing a product to enhance or improve it often requires regulatory re-approval before releasing to the market. The regulatory environment itself is ever changing in response to new technological advancements, product performance and demand for alignment of systems and expectations.
Triskele Consulting has successively managed all kinds of transitions including those arising from remediation (corrective and preventive actions), progressive transition including changing international standards, product change management and re-approval. We are actively engaged in the impact of the EU Medical Device Regulation on the industry. We can help you ensure readiness and manage the CHANGE affecting you and your business within the medical device industry.
Quality Management System package to EN 13485/CFR Part 820 and EU MDR
Management Representative Function
Design and Development Planning
Sterilization Validation Requirements guidance
Process Validation, Sample Size planning and Implementing Control Plans
Internal Audits (available qualified Lead Auditor ISO 13485, ISO 9001)
Supplier Audits (available qualified Lead Auditor ISO 13485, ISO 9001)
Regulatory Planning & Strategy Development
Change Control, best practice guidance and implementation
Corrective Action, Preventive Action (CAPA) Support