Health Canada & MDSAP

Healthcare Regulatory Canada MDSAP Compliance Quality Management

Overview

The Health Canada & MDSAP skill helps Rakenne users in the Canadian health sector align their quality management system (QMS) documentation with the Medical Device Single Audit Program (MDSAP) and Health Canada expectations. It guides you to map procedures, work instructions, and records to MDSAP/ISO 13485 requirements, prepare for or interpret MDSAP audits, and—when available—use the mdsap_audit_aligner skill to map QMS content to MDSAP standards.

Health Canada requires MDSAP for Class II, III, and IV medical device licenses (transition completed in 2019). The skill covers the MDSAP audit model (based on ISO 13485 plus jurisdiction-specific appendices), common gap areas (design controls, risk management, complaint and adverse event reporting), and the use of the built-in checklist template to track alignment.

Key Features

Scope clarification — Confirms device class (II, III, IV), audit type (initial, surveillance, responding to findings), and available QMS documentation.
QMS-to-MDSAP mapping — Maps your quality manual, procedures, and records to MDSAP/ISO 13485 requirement areas and the Canadian appendix (complaint handling, adverse event reporting).
Gap identification — Flags missing or weak coverage (e.g. design controls, risk management file, mandatory problem reporting) with clear recommendations.
Alignment checklist — Uses the built-in checklist template to track requirement coverage; copy and fill per audit or project.
mdsap_audit_aligner integration — When the environment includes the mdsap_audit_aligner skill, runs it against your QMS docs and incorporates its output into the alignment report.

Getting Started

Add your QMS documentation (quality manual, procedures, design controls, risk management, production and post-market procedures) to the project workspace, then activate the Health Canada & MDSAP skill. The agent will ask for device class, audit type, and jurisdiction(s), then map your documents to MDSAP requirements and produce an alignment or gap report. Use the checklist template to track status; address gaps and re-run the alignment to confirm coverage before the audit.

Example Conversation

Below is an example of how a typical MDSAP alignment session unfolds. The agent gathers scope and QMS context, then maps documentation to MDSAP and produces an alignment report.

You: We’re preparing for our first MDSAP audit for Health Canada. Can you map our QMS procedures to MDSAP requirements?
Agent: I’ll align your QMS documentation to MDSAP and Health Canada expectations. I need a few details:
What device class(es) are in scope? (Class II, III, or IV for Canada.)
Are you preparing for an initial MDSAP audit, surveillance, or responding to findings?
Which documents do you have in the workspace? (e.g. quality manual, design control procedure, risk management file, complaint handling, production controls.)
You: Class III implant. Initial MDSAP audit. I’ve added our quality manual, design control SOP, risk management procedure, and complaint handling procedure to the project.
Agent: I’ve mapped your documents to the MDSAP audit model and created an alignment report at output/mdsap-alignment-report.md. Summary:
Covered — QMS general (quality manual); management responsibility; design and development (your SOP plus DHF references); complaint handling (procedure addresses Canadian requirements). Risk management procedure is present and references ISO 14971.
Partial — Production and process validation: your manual references validation, but there’s no dedicated procedure or template for process validation (IQ/OQ/PQ). Post-market surveillance: mentioned in the manual; recommend a short procedure or work instruction that links to risk management and adverse event reporting.
Missing — Adverse event / mandatory problem reporting: Health Canada has specific timelines and reporting; your complaint procedure doesn’t yet call out mandatory problem reporting to Health Canada. I’ve added recommended actions and a checklist at output/mdsap-alignment-report.md. I can draft a one-page addition to your complaint procedure for mandatory problem reporting if you’d like.
You: Yes, draft the mandatory problem reporting section and add a short post-market surveillance procedure outline.
Agent: I’ve added a draft “Mandatory problem reporting (Health Canada)” section for your complaint procedure and a one-page post-market surveillance procedure outline in the workspace. The alignment report and checklist are updated. After you review and adopt these, we can re-run the alignment to confirm the previous gaps are closed.

Sample Output Excerpt

Below is a representative excerpt from an MDSAP alignment report produced by the skill — the main deliverable the agent generates.

Alignment summary (excerpt)

Area	Requirement summary	Your document(s)	Status	Notes
4 QMS	Quality management system, documentation	Quality Manual v2.1	Covered	Scope, exclusions, and structure align.
7.3 Design and development	Planning, inputs, outputs, review, V&V, transfer, DHF	Design Control SOP; DHF references in SOP	Covered	DHF location and retention stated.
7.5 Production and service provision	Process validation, traceability	Quality Manual §7.5; no dedicated validation SOP	Partial	Add procedure or template for process validation (IQ/OQ/PQ).
Risk management	ISO 14971; risk file; design and post-market linkage	Risk Management Procedure	Covered	References risk file and design/post-market.
Complaint handling (Canada)	Procedure and records; Canadian MDR	Complaint Handling Procedure	Covered	Includes receipt, investigation, closure.
Adverse event / mandatory problem reporting (Canada)	Timelines and reporting to Health Canada	—	Missing	Add to complaint procedure or separate SOP; include Health Canada reporting timelines.
Post-market surveillance	Monitoring, feedback, input to risk and CAPA	Mentioned in Quality Manual	Partial	Add short procedure or work instruction linking to risk and adverse events.

Gaps and recommendations (excerpt)

Adverse event / mandatory problem reporting (Canada) — Missing. Health Canada requires mandatory problem reporting per the Medical Devices Regulations. Add a section to your complaint handling procedure (or a dedicated SOP) that defines reportable events, timelines, and submission to Health Canada. Reference Health Canada guidance and keep records of submissions.
Production and process validation — Partial. Your quality manual requires validation of processes where the resulting output cannot be verified by subsequent monitoring. Add a procedure or template that covers validation planning, IQ/OQ/PQ (or equivalent), and revalidation criteria. Reference it in the manual.
Post-market surveillance — Partial. Define how you collect and review post-market data (complaints, adverse events, literature, field data), how it feeds into risk management and corrective action, and where it is documented. A short procedure or work instruction is sufficient.

What the analysis checks

The skill does not include separate validation scripts; the agent performs alignment and gap analysis using the workflow in the skill and the reference document. The following checks are applied so the alignment report is accurate and useful for MDSAP and Health Canada.

Check	Description
Scope alignment	Device class (II, III, IV) and audit type (initial, surveillance, findings response) are confirmed so the right requirement set and Canadian appendix are used.
ISO 13485 coverage	Each major ISO 13485 clause area (QMS, management responsibility, resources, product realization, measurement and improvement) is matched to your documentation. Missing or vague coverage is flagged.
Design controls	Design and development planning, inputs, outputs, review, verification, validation, transfer, and design history file are checked for presence and traceability.
Risk management	Risk management file and procedure aligned with ISO 14971, and linkage to design and post-market activities, are verified.
Canada-specific	Complaint handling and adverse event / mandatory problem reporting procedures and records are checked against Canadian Medical Devices Regulations and Health Canada expectations.
Production and process validation	Where output cannot be verified by subsequent monitoring, validation (e.g. IQ/OQ/PQ) is expected; the agent flags absence of a dedicated procedure or template.
Post-market surveillance	Evidence that post-market data (complaints, adverse events, field feedback) is collected, reviewed, and fed into risk management and corrective action is checked.
mdsap_audit_aligner output	When the mdsap_audit_aligner skill is available, its output is incorporated into the alignment report and checklist so coverage is consistent with the aligner’s mapping.

The agent uses the skill’s reference (references/health-canada-mdsap-basics.md) and the built-in checklist template (assets/mdsap_alignment_checklist.md) to keep the report actionable and aligned with Health Canada and MDSAP expectations.