Development & design controls
Practical support from early product definition through design transfer, including development planning, design inputs, architecture, traceability and technical documentation.
Medical device development consultancy
Complex development.
Clear direction.
Practical, senior-level support for medical device organisations navigating development, software, risk, cybersecurity and compliance.
From uncertainty to
defensible evidence
StrategyExecutionAssurance
What we do
Support where technical development and regulatory expectations meet.
We help established organisations, development teams and growing medtech companies turn complex requirements into proportionate plans, working processes and credible evidence.
Consulting services
Focused expertise.
Joined-up thinking.
Risk management
Risk management frameworks, plans, analyses and reviews aligned with ISO 14971 — integrated with development rather than treated as a standalone exercise.
Software lifecycle
IEC 62304-aligned lifecycle processes, software planning, safety classification, architecture, requirements, verification and supplier oversight.
Product cybersecurity
Security planning, threat modelling, security requirements, SBOM and VEX, vulnerability management and evidence for connected medical devices.
Verification & validation
Strategies, plans, protocols and evidence structures that connect product requirements, risk controls and intended use to defensible results.
Audit & remediation support
Focused gap assessments, audit preparation and prioritised remediation for organisations that need to make credible progress quickly.
How we work
Experienced support, shaped around your challenge.
Every engagement starts with the problem, not a predetermined package. PG Consulting provides a clear point of accountability and can draw on established relationships with complementary specialists when the scope calls for it.
Right-sized expertise
We assemble support around the work required, drawing on trusted specialist relationships where a broader team is needed.
Useful deliverables
Plans, procedures and evidence are designed to be used by your teams — not simply filed for an audit.
Clear priorities
We distinguish urgent compliance gaps from longer-term improvements and make the next decisions visible.
Start a conversation
What are you trying to move forward?
Tell us a little about the device, the challenge and any important timescale. We’ll respond to arrange an initial, no-obligation discussion.
enquiries@pg-consulting.net