Programme Governance
Project Management in an ISO 13485 Environment: Delivering NPI Without Bending Your QMS
How to run schedules, budgets and phase gates in an ISO 13485 environment without bending your QMS into a project tool.
Arcturus Pro Blog
Practical guidance on project governance, ISO 21502, risk management and NPI delivery for regulated manufacturing teams.
Microsoft has confirmed Project Online reaches end of service on 30 September 2026. For regulated manufacturing and med-tech teams, this is not just a software migration — it is a compliance risk if handled without a plan. What you need to do now.
Read articleAll articles
How to run schedules, budgets and phase gates in an ISO 13485 environment without bending your QMS into a project tool.
Decisions made in project meetings rarely make it into formal project records on the same day. This post examines why the meeting-to-record gap exists, what it costs...
The project sponsor is the most important role on any capital or NPI project, and the most misunderstood. Here is what the role actually requires.
Most risk registers in manufacturing are created at project kick-off and never opened again. Here is how to build one that stays alive.
The decision guide for regulated manufacturing teams evaluating Project Online alternatives. Five criteria that matter, a comparison of the main options, and the questions to ask any vendor.
The PMI AI Standard gives regulated project managers a compliance-defensible way to adopt AI tools. What the standard says, what it means in practice, and what to avoid.
PMI released its first standard on AI in project management. What it covers, what it does not cover, and what it means for teams in regulated manufacturing and med-tech.
A practical guide to writing a project charter for manufacturing and med-tech NPI projects. What sections to include, what most teams leave out, and why the charter is the single most important document before design controls open.
Most projects go off track not because of bad ideas, but because nobody was checking at the right moments. What to review at each phase, who approves it, and how to keep your NPI on track.
A practical comparison for NPI programme managers. What each framework actually is, where they overlap, and which carries most weight in a customer audit or supplier qualification.
What poor project governance costs Irish medical device contract manufacturers in ISO 13485 findings, NPI delays, and OEM customer confidence.
Most manufacturing PMOs overestimate their process maturity. The 5 maturity levels explained, what separates Level 2 from Level 4, and how to run a quick diagnostic for your team.
Excel is free, familiar, and flexible. But it is costing your team more than you think. A frank breakdown of where spreadsheets fail in regulated manufacturing environments.
ISO 21502:2020 is the international standard for project management. What it means for regulated manufacturers in Ireland and why it is increasingly expected by customers and regulators.
A 20-minute call. No slide deck, just the system working on a real manufacturing project.
Book a Discovery Call