SIGNATURE REMOTE QMS IMPLEMENTATION
Build a QMS that fits your operation
Our remote QMS consulting supports startups, growing manufacturers and established businesses. Through focused working sessions, document review and implementation coaching, we help your team put the management system into daily use.
The right fit
Who this service is for
- Small and midsize medical device companies needing FDA QMSR alignment
- Canadian manufacturers addressing applicable Health Canada medical device requirements
- Organizations implementing ISO 13485 or an integrated ISO 9001, 14001 and 45001 management system
- Existing manufacturers improving fragmented quality systems or excessive documentation
Scope & expertise
What we can assess or deliver
- Applicability and gap assessment for ISO 13485:2016 and FDA QMSR / 21 CFR Part 820
- Assessment of applicable Canadian Medical Devices Regulations and requirements related to MDSAP
- Process maps, document architecture, roles, responsibilities and record design
- Risk management interfaces, supplier controls, purchasing, production, complaint handling and CAPA
- Management review, internal audit, performance monitoring and change control
- Implementation coaching, employee training, evidence review and readiness exercises
A clear way forward
How the engagement works
Discovery and regulatory scope
Understand device types, activities, sites, jurisdictions, outsourcing and existing processes.
Prioritize the system
Develop a lean implementation plan with owners, deliverables and priorities based on risk.
Build collaboratively
Draft or refine process documents using live remote workshops and your team’s workflows.
Implement in operations
Coach staff as they generate real records, conduct reviews and operate controls.
Verify and improve
Perform a readiness review and address implementation gaps before external scrutiny.
Tangible deliverables
Typical project outputs
- Scope and applicability assessment
- Phased implementation roadmap and document register
- Procedures, forms and records developed for your business, as agreed
- Training, implementation evidence and readiness summary
Onsite observation or specialist testing may be necessary depending on product, processes and risk. Regulatory obligations depend on the manufacturer’s actual activities and markets.
Start a conversation
Request a tailored proposal
Only company name, contact person and email are required. Choose the options that apply; there is no need to write a lengthy specification.