MediqWise provides regulatory standards and guidance monitoring for medical device, SaMD, and digital health companies that need a practical way to stay informed without building a full internal monitoring process too early.
The service helps clients identify relevant changes, understand why they may matter, and receive clear reporting that can support regulatory intelligence, QMS planning, management review, submission planning, and post-market activities.
Monitoring frequency
Regulatory standards and guidance monitoring can be provided monthly, quarterly, or semi-annually, depending on the client’s quality system, regulatory markets, product lifecycle stage, and internal review process.
The frequency can be adjusted as the company’s product portfolio, market presence, and regulatory obligations evolve.
What is monitored
The monitoring scope is customized based on the client’s products, markets, and applicable standards or guidance.
Common sources may include:
- FDA guidance and recognized consensus standards
- Health Canada guidance and recognized standards
- EU MDR / IVDR, MDCG guidance, and harmonised standards updates
- MHRA guidance and designated standards
- TGA, Medsafe, and IMDRF updates, where applicable
- New, revised, withdrawn, or under-development ISO and IEC medical device standards
What the report may include
Each report can be tailored to the client’s needs. Common report sections include:
- Executive summary
- Key regulatory signals
- Newly issued or revised guidance
- Newly recognized, published, revised, withdrawn, or obsoleted standards
- Standards under development or revision
- Jurisdiction-based update summaries
- Impact summary and recommendations
- Suggested action items, applicability, and compliance risk ratings, where appropriate
Who this service is for
This service is especially suitable for startups and early-stage medical device, SaMD, and digital health companies that need structured regulatory intelligence without unnecessary complexity.
It may be useful for companies that:
- Sell or plan to sell products in multiple jurisdictions
- Need periodic standards and guidance monitoring for QMS or management review
- Have limited internal regulatory intelligence capacity
- Want practical summaries instead of raw update lists
- Need help identifying which updates are meaningful and which are informational only
Please contact MediqWise Regulatory & Quality to discuss your monitoring scope, reporting frequency, and preferred report format.