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DIGITAL SME Summit 2026Moebiusol presenting · Brussels · 16 November
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ISO13485
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Procedures, responsibilities and records applied to development work

QMS & Regulated Development Consulting

Establish or improve a documented regulated-development framework. We assess current practices, assign process and review responsibilities, and prepare procedures, templates and registers for requirements, risk, design, change, configuration and verification. Applying the framework to a representative change shows which records and links the team needs to maintain.

Regulated development framework
  1. 01Gap assessment
  2. 02Procedures & templates
  3. 03Traceability & review
Apply the framework to a representative product change.

Your starting point

Who this is for

  • Startups establishing their first regulated-development framework
  • Organisations improving an existing quality management system
  • Delivery teams facing unclear responsibilities, missing records or documentation catch-up

Customer value

What this helps you do

Defined review responsibilities

The process map and responsibility matrix identify who prepares, reviews and approves the agreed records.

Records tied to a change

A representative walkthrough tests how requirements, decisions and verification evidence stay connected.

Where we can help

Service scope

Assess the records already in use

Examine requirement documents, risk and design records, change controls and verification evidence. Identify missing links, duplicate records and unclear review ownership in a prioritised assessment.

Define the process and document set

Agree who authors, reviews and approves each activity. Prepare procedures, templates and registers that identify the required inputs, records and responsibility boundaries.

Apply the framework in existing tools

Work through a representative development change with the team. Connect the requirement, design decision, change record and verification evidence using the agreed traceability approach.

Hand over maintenance responsibilities

Review the resulting records and unclear controls with their owners. Provide adoption sessions and a list of readiness findings and further improvements for the organisation to resolve.

Tangible outcomes

What you receive

  • Current-state gap assessment and prioritised improvement roadmap
  • Process map and authorship, review and approval responsibility matrix
  • Tailored development procedures, templates and registers
  • Traceability approach, adoption material and readiness findings

Working with your team

How we work together

  1. Assess and agree scope

    Inspect current practices and records, prioritise gaps and identify the organisation’s process and document owners.

  2. Prepare and apply the framework

    Co-author the agreed procedures and records, then use them on representative development work.

  3. Review use and hand over

    Review the records produced, adjust unclear controls and hand remaining improvement actions to their owners.

Illustrative engagement

Illustrative scenario: a growing software team has separate requirement documents, risk files and test records with inconsistent review ownership. We assess the gaps, agree responsibilities and co-develop a documented development workflow. Applying it to one representative change reveals where templates and links need adjustment. The client approves the framework and assigns owners for ongoing use, review and improvement after handover.

Make your quality framework work for your team

Tell us whether you are establishing a QMS or improving one, and where processes or records are holding development back. We can scope practical support around those gaps.

Simplify your quality framework