Programme & Project Management

Precision. Compliance. Trust.

Our capabilities

Effective programme management is essential in regulated medical device development and transfer. Our approach focuses on creating structure, clarity, and alignment across teams — enabling predictable execution even in complex, compliance driven environments.

When complexity grows and programme risk increases, we bring structure and clear governance

Clear Stage Gates and Governance

Large, multi-stream medical device programmes often struggle with misaligned assumptions, unclear decision paths, and issues that surface too late. To help teams navigate this, we use a phased stage gate model across concept, feasibility, development, verification, validation, and launch — with clearly defined responsibilities via a RACI at each stage. Planning cadence includes weekly work stream syncs, bi-weekly steering and monthly portfolio reviews.

Regular steering forums supported by concise, exception based dashboards

Clear escalation pathways so decisions are made quickly and confidently

Shared tracking tools and joint working groups to improve transparency

Gate criteria that stabilise scope, design maturity, and process readiness

This reduces scope creep, provides timely visibility, reduces rework by freezing items such as design and BOM at the right time, and helps teams progress with confidence.

Decision latency (steerco actions closed by date) ≥ 95% and stage gate exit rate is typically 90-95%.

When plans threaten to slip, we use an integrated master plan everyone can rely on

Integrated Master Planning

Programme delays often arise because engineering, tooling, validation, and supply chain teams are working to disconnected schedules. To bring everything into alignment, we use an Integrated Master Plan (IMP) / Integrated Master Schedule (IMS) that connects all programme streams into a single, event driven roadmap.

Mapping cross functional dependencies

Modelling resources and understanding financial implications

Analysing the critical path and running scenario simulations

Integrating tooling, metrology, validation, and regulatory activities

This approach reveals schedule risks earlier and reduces bottlenecks between teams which leads to improved on-time launch performance.

Average milestone adherence is 95%.

When requirements start to drift, our established traceability protects design intent

End to End Traceability

Ambiguous or poorly tracked requirements can cause verification gaps and late redesign during DV/PV. To prevent this, we implement a requirements management system that links user needs, design inputs, test methods, and fixture/measurement readiness.

End to end requirements capture with clear ownership

Early development of test methods and jigs/fixtures

Objectively defined pass/fail criteria

Process validation orchestration (IQ/OQ/PQ)

This strengthens traceability, reduces late stage churn, and helps safeguard regulatory compliance.

Requirements volatility after design freeze record: ≤ 2%

When risks aren’t managed well, issues grow into critical path blockers

ISO 14971 Risk Management

Without structured risk management, problems tend to surface late and impact cost, schedule, or compliance. We apply ISO 14971 aligned risk processes at both the product and programme levels.

Programme level RAID logs linked directly to DFMEA/PFMEA outputs

Clear mitigation owners, triggers, and follow through

Cross functional dashboards that highlight high severity risks

Integration of risk controls into validation and process development

This helps teams identify emerging issues early and manage them through consistent, documented controls.

Risk burn down rate: ≥ 80% of high risks mitigated before DV start

When budgets tighten, we maintain financial discipline without losing momentum

Strong Financial Controls

Costs in tooling, validation, or supplier deliverables can shift quickly. We maintain financial governance.

Ongoing CAPEX/OPEX tracking

Estimate at Completion (EAC) monitoring

ROI/NPV modelling for major decisions

A Quvara “QValue” process that identifies and delivers shared cost reduction or value enhancement opportunities

These controls provide early insight into cost drivers and enable thoughtful financial decision making.

Cost variance at completion (CVA): ≤ ±5%

When suppliers slip, we help integrate partners into the programme

Supplier Management

External partners can sometimes operate outside the core programme’s visibility, exposing teams to risk. We bring suppliers into the programme by using:

Joint programme plans and aligned supplier reviews

Clear communication and escalation channels

Shared risk registers

Tooling, materials, and validation readiness dashboards

This creates clearer expectations, reduces external dependency delays, and supports smoother scale up and transfer.

Supplier On Time Delivery to program plan: ≥ 98%

When you need a true partner, we align goals and foster transparent communications

Collaboration and Visibility

Many programmes struggle not because of technical issues, but because teams lack shared visibility. We help build alignment with clients through:

Voice of the customer, user needs and requirements engineering

Joint workshops on FMEAs, risks and cost improvement opportunities

Shared project plans and collaborative tracking documents

Integrated validation support and cross functional reviews

This promotes a collaborative, aligned partnership, faster problem solving and keeps teams moving in the same direction. Data is managed according to ISO 27001 to ensure security of information for all parties.