CLINVISE SERVICES
Regulatory Documentation Support
Bring your medical device documentation into a clear, organised structure and identify what needs attention next. We support technical documentation preparation, gap analysis, and review for your device and target market, with agreed deliverables and responsibilities
from the start.
WHAT IT IS
Organise the files. Identify the gaps. Agree the next step.
We support documentation preparation, gap analysis and review for an agreed medical device and target market. We help you organise the information already available and identify what needs further work. Formal submissions, assessments and approvals remain with the appropriate authorised channels.
ClinVise supports preparation and review. We do not act as a Notified Body, Authorised Representative or regulatory submission agent. We do not submit to authorities on your behalf, issue certificates or conduct clinical investigations. Submissions and formal assessments remain with the appropriate authorised channels.
THE CHALLENGES
The challenges your team may face.
Files in different places
Documents, evidence and versions are spread across folders or different team members.
Missing or inconsistent information
You need a clearer view of the material that is available and the gaps that remain.
Unclear responsibilities
Source inputs, reviewers and formal submission roles have not been clearly agreed.
THE CLINVISE SOLUTION
How ClinVise helps.
We organise your available documentation, identify missing or inconsistent information, and agree on the preparation work needed next. We establish the required inputs, reviewers, and responsibilities before starting.
Structure the package
Organise the supplied material into an agreed documentation structure.
Identify the gaps
Review the available information and highlight missing or inconsistent material.
Define the next step
Agree the device, target market, inputs, responsibilities and deliverables before sensitive files are requested.
WHAT THIS COVERS
Explore documentation support by market.
- Technical documentation structure and compilation.
- Device classification guidance based on the product context.
- General Safety and Performance Requirements mapping.
- Clinical Evaluation Report support, including literature and evidence organisation.
- Risk management documentation support.
- Labelling, Instructions for Use and UDI-related documentation review.
- Quality Management System documentation structure and gap identification.
- Post-Market Surveillance plans and Periodic Safety Update Report templates.
Support with UK market documentation preparation, UK Responsible Person requirements and the information needed for MHRA registration, within the agreed preparation role.
- 510(k) package preparation support, including device description, predicate comparison and performance-data summaries.
- Device classification and product-code guidance.
- Preparation of establishment registration and device listing information.
- Labelling documentation review.
Preparation support for medical device registration, manufacturing and import licence documentation, and documentation associated with GMP inspections. The applicable pathway and document set are established for the device and activity.
Documentation awareness and preparation support may include Health Canada, Australia’s TGA, relevant Gulf markets and WHO prequalification needs. We confirm the fit, responsible specialist and scope before accepting work.
Detailed applicability is established during scoping. We confirm the fit, responsible specialist and scope before accepting work.
Additional support
- Regulatory strategy consultation on market priorities and documentation pathways.
- Gap analysis to identify missing or inconsistent material.
- Regulatory intelligence relevant to the agreed product and market.
- Referrals for specialist services outside our role, including authorised representation, notified body assessment and clinical investigation management.
WHO THIS IS FOR
A defined device. A defined documentation need.
Small manufacturers preparing their first device documentation package, companies entering a new market, and teams whose existing files need review or restructuring before submission.
HOW WE START
Share a high-level description of the device, intended use, target market, current stage and the documents already available. We agree the review scope, source inputs, responsibilities and deliverables before requesting sensitive files.
Your questions, answered.
Can you guarantee approval or a completion date?
No. The scope covers agreed preparation and review activities. Authority decisions and timelines are outside our control.
Do you also review marketing wording?
Yes. Regulatory-Ready Marketing is the connected service for product communication and claim review.
YOUR NEXT STEP
Discuss your regulatory readiness.
Share a high-level device description and target market. We agree the scope before requesting sensitive files.