Quality Management System (QMS) Implementation

ISO 13485: 2016/ QMSR for Medical Devices

A robust, compliant Quality Management System (QMS) is the backbone of every successful medical device and SaMD organisation. At Simplimedica Ltd, we design, implement, and optimise QMS frameworks tailored to your technology, business model, and regulatory obligations. Whether you’re developing traditional hardware devices, combination products, or cutting-edge Software as a Medical Device, we help you achieve ISO 13485:2016 certification, support global submissions, and embed a culture of quality throughout your organisation.

QMS for ISO 13485:2016 Compliance

We build fully compliant QMS structures aligned with ISO 13485:2016, covering all aspects of medical device design, development, manufacturing, and post-market activities. Our services include:

Complete QMS Design & Implementation

✱ Development of a bespoke QMS aligned with your device type, company size, and regulatory strategy.

✱ Full documentation suite: Quality Manual, procedures (SOPs), work instructions, templates, and records.

✱ Integration of risk management methodologies compliant with ISO 14971.

Procedure Development & Documentation

We create and implement all required ISO 13485 procedures, including:

✱ Design & development controls

✱ Supplier and purchasing controls

✱ CAPA, NCR, and complaint handling

✱ Production, validation, and process controls

✱ Document & record management

✱ PMS, PMCF, and vigilance procedures

Internal Audits & Gap Assessments

✱ Full gap analysis of your current system against ISO 13485 and MDR/IVDR requirements.

✱ Internal audits and readiness assessments before external Notified Body or certification audits.

Support Through Certification

We guide you through the entire certification journey:

✱ Selecting a certification body

✱ Preparing for Stage 1 Stage 2 audits

✱ Managing audit responses and corrective actions

Build a Compliant, Scalable, and Audit-Ready QMS

Whether you need to upgrade an existing system, build a new ISO 13485 QMS from the ground up, or integrate IEC 62304 for SaMD development, Simplimedica delivers a quality system that supports innovation without slowing you down.

Speak with a Regulatory Specialist Today

QMS for Software as a Medical Device (SaMD)

Regulatory-Ready Software Quality Management

Developing SaMD requires additional software-specific controls. We implement a complete software-aligned QMS, integrating ISO 13485 with key software and cybersecurity frameworks.

SaMD-Specific Elements We Implement

IEC 62304-compliant software development lifecycle (SDLC)
IEC 82304-1 user safety and software product validation
Cybersecurity risk management aligned with IMDRF, MDCG guidance, and FDA expectations
Agile-compatible documentation and change control processes
Clear traceability from user needs → requirements → architecture → verification → validation

SaMD Documentation Suite Includes

Software Requirements Specification (SRS)
Software Architecture Documentation
Risk management files linked to software hazards
Verification & Validation (V&V) protocols and reports
Configuration management & version control procedures
DevOps/CI-CD quality controls (where applicable)

Post-Market Lifecycle Controls

For adaptive, cloud-based, or continuously updated SaMD, we implement:
Update management & change impact assessment
Real-world performance monitoring
Complaint handling & field actions
Cybersecurity surveillance and patching processes

Global Regulatory Alignment

Our QMS implementations support compliance for:
EU MDR / EU IVDR
UKCA
FDA QSR (21 CFR Part 820) and the upcoming QMSR
Health Canada
Australia TGA
IMDRF SaMD & software regulatory models

Whether you’re preparing for CE marking, FDA clearance, or global market expansion, your QMS will be designed to support your entire regulatory roadmap.

Why Choose Simplimedica?

Experts in both traditional medical devices and SaMD/AI/ML products
End-to-end support — from gap assessments to full implementation and certification
Systems tailored for start-ups, SMEs, and scaling companies
Efficient, compliant documentation without over-burdening your team
Practical, industry-tested templates and lean processes
Strong integration of software, clinical, regulatory, and quality expertise