Trinzo

We believe that success in t h i s

Trinzo provides the best global talent to
our clients. Our team is committed to
providing the right results, at the highest of
standards, in the simplest of ways. Our aim
is to navigate our clients through the
complex and ever changing regulatory
environment. We promise to maximise
your business potential, as your success is
our passion.
Helping you, Help your patients
industry is driven by having a solid
✓ Compliance Management
foundation in Quality and
✓ QA/RA Remediation Regulatory Culture
✓ Audit and Inspection
We believe in listening to, and
✓ Project Management collaborating with our clients t o
✓ Quality System identify and fully understand t h e i r
✓ Quality Culture Change & challenges in order to p r o v i d e
them with a bespoke solution.
Development
✓ Behavioural Based Quality
We believe that by m a x i m i z i n g
✓ Organisation Design
their business potential, our clients
✓ Interim Leadership can improve patient lives.
✓ Training
✓ Behavioural Based Quality
✓ Customised MDR preparation

Trinzo
Level One P: +353 091 394804
Liosban Business Park E: info@trinzo.com
Tuam Road W: www.trinzo.com
Galway City, Co. Galway
Ireland

Maximising Business Potential


We work with medical device companies to help
solve their quality and regulatory challenges. We
provide global compliance, remediation and
project
management services to the Medical Device
Industry by utilising our team’s combined 500
years of experience, industry
leading methodologies and expertise to provide
a bespoke solution for your business needs.
By utilising our experience we can provide the
best team, with the most experience to help you
anywhere in the world. This allows us to focus on
providing sustainable solutions and
results that enable our clients to flourish and
thrive.
We guarantee our team remain the best, with the
most up to date knowledge which allows us to
seamlessly become an extension of your
organisation , driving improvement and long
lasting positive change.
During this phase we will assess all
relevant information required to estab-
lish the current status, desired status,
constraints and any other relevant
information. Wecollect data through a
variety of assessment methods, ana-
lysing the data in order to complete a
plan.
During this phase, we will develop a
structured plan. This will outline how
we will be successful in achieving the
objectives in the charters. This plan
will include the key milestones and
resources needed at each stage of
execution in order for the project to be
successful.
During this phase we will execute the
Plan in line with the agreed charters.
We will report on the progress being
made at predefined intervals. We will
continuouslyreview the outcomes
under an appropriate governance
structure in order to ensure that they
have had the desired result.
✓ Education and Regulatory Training
✓ Digital, On-site, Events, Workshops
✓ Upper Level Management Workshops
✓ Business Impact Assessment and Consultation
✓ Portfolio Review, Analysis and Rationalisation
✓ Prioritisation and management of risk areas
✓ QMS Impact
✓ Post-Market Surveillance & Vigilance
✓ Supply Chain and Economic Operators
✓ Labelling
✓ Clinical Evidence & Evaluation
✓ Traceability & UDI
✓ Classification & Scope
✓ Resourcing and Managing the best talent on
the market
✓ Project Managers, Subject Matter and Industry
Experts, Person Responsible for Regulatory
Compliance
✓ Management of detailed project plans to meet
key objectives