MedQraft Consulting
We review your documentation alongside your actual workflows.
A framework suited to your organization, with records the next person can build on.
Start by understanding the work
Documents exist, but work is done differently on the floor.
Staff changes have scattered revision histories and follow-up tasks.
MedQraft reviews current operations and records together,
then defines the scope of the work to address.
01 / Scope of support
You do not have to start with a full implementation.
We can focus on the work you need to address.
Compare procedures and forms with actual operations to define improvements to documents, responsibilities and records.
Document registers · Revisions · Distribution · ResponsibilitiesOrganize preparation items, available records and follow-up tasks around your audit scope and timeline.
Preparation items · Record review · Follow-up questionsReview findings and progress, then define the scope for reviewing action plans, evidence and effectiveness checks.
Finding review · Action plans · Follow-up checksBuild processes, responsibilities, documents and records step by step, taking your products and organizational scale into account.
Workflows · Procedures · Forms · RecordsReview documents and operations and provide follow-up support within the agreed scope as your organization and workflows change.
Periodic review · Change updates · Operational support02 / Sample deliverables
Using a mismatch between a document register and the version in use,
we show how observations lead to follow-up tasks.
This is a fictional example to illustrate the work.
It is not a client case study or a conformity determination.
Document review / Document control improvement
If the revision in a register differs from the file in use,
compare the latest approved version, effective date and actual usage.
03 / How we work
We review your operations, the work to address and your target timeline.
You do not need to send all technical documents at the outset.
We define the work, deliverables, exclusions and the cooperation needed from your team.
The scope and fees for detailed document review are agreed first.
We complete the agreed work and explain the deliverables and follow-up questions.
04 / FAQ
Yes.
We define the work and deliverables around your needs, such as document control improvement, audit preparation or findings follow-up.
We review current documents and actual work, then distinguish what can be retained from what needs improvement.
Any need for a complete revision is discussed within the review scope.
Consulting and software adoption are considered separately.
If you need a business system, we can also discuss Q-Atelier or a system tailored to your organization.
Briefly describe your current operations, the work you need and your timeline.
We will discuss the materials to review and how to share them afterwards.
MedQraft / Get in touch
Tell us three things.
You do not need a finished plan or technical documentation.
We will review the questions and define a suitable scope of support.
The current stage of your product and operations
The work you want to review or improve first
When you want to be ready
Medical device development, regulatory and quality work.
We review your current situation and agree on the support and deliverables you need.