APPLICATION 01
Device manufacturers
Connect design and production controls with regulatory responsibilities.
INTERNATIONAL / MEDICAL DEVICE QUALITY
ISO 13485.
Quality for medical technology.
Prepare a medical device quality management system that connects regulatory responsibilities, product realization and controlled records, with support for process assessment, implementation evidence and independent ISO 13485 certification readiness.
Scope review · Documentation · Coordination
MEDICAL DEVICE QUALITY
International
ISO 13485
SERVICE AT A GLANCEISO 13485 Medical Device QualityInternational
YOUR MARKETInternational
YOUR FOCUSMedical device quality
OUR APPROACHConnected compliance support
FROM THE DETAILSTo the
possibilities.CLARITY AT EVERY STEP
possibilities.CLARITY AT EVERY STEP
Built around your organization.
Focused on your next market.
Focused on your next market.
01 / THE BIG PICTURE
Understand the requirements.
See the opportunity.
ISO 13485 is a quality management system standard developed for medical devices and related services. Its focus on regulatory purposes makes the organization’s role, product activities and applicable market obligations central to implementation.
Complise Global supports businesses in translating those responsibilities into working processes and records. The preparation needs to distinguish the quality system from a device’s separate registration, technical assessment or authorization in any destination market.
Explore the requirements02 / WHERE IT APPLIES
Teams and operations.
A shared focus on improvement.
Start with your activities, sites and customer expectations. Here are some of the organizations and operations covered by this service.
APPLICATION 02
Specialist suppliers
Define quality controls for components and outsourced processes.
APPLICATION 03
Device service businesses
Manage installation, servicing and related quality records.
These are examples. The scope depends on your activities, sites and the selected standard or programme.
03 / THE PATH FORWARD
From assessment
to a clear outcome.
Connect scope review, implementation and assessment with a plan suited to your organization.
Define the role
Map activities, sites and regulatory context.
Assess the processes
Identify gaps and critical quality controls.
Implement the records
Build traceable operational evidence.
Prepare certification
Review effectiveness before independent assessment.
One connected workflow, with your organization at the center.
Create your project brief04 / EXPLORE THE DETAILS
Your requirements.
The details, made clear.
Open a topic for guidance on scope, requirements, documentation and practical considerations.
6 topics in this guide
CHAPTER 01Define the device business scopeClarify the organization’s role in design, manufacture, installation, servicing or related supply activities. Identify which…
Clarify the organization’s role in design, manufacture, installation, servicing or related supply activities. Identify which sites and processes belong in the system. This prevents a generic quality manual from claiming responsibilities the business does not actually perform.
CHAPTER 02Connect market obligations to processesDetermine how relevant regulatory requirements enter design decisions, product records and customer communication. Maintain…
Determine how relevant regulatory requirements enter design decisions, product records and customer communication. Maintain ownership for monitoring changes. A certificate can support a regulatory strategy, but it does not by itself establish approval to sell every device in every market.
CHAPTER 03Control product realizationMap how specifications become a delivered device or service. Define the records needed to demonstrate that each stage was…
Map how specifications become a delivered device or service. Define the records needed to demonstrate that each stage was completed appropriately. Address outsourced processes and supplier interfaces with the same care as in-house work.
- Supplier and purchasing controls
- Production or service verification records
CHAPTER 04Apply risk-based quality controlsIdentify where process failures could affect device conformity and assign suitable controls. Review validation needs, change…
Identify where process failures could affect device conformity and assign suitable controls. Review validation needs, change management and competence requirements for the actual operation. Evidence should show how decisions were made and why the chosen control is adequate.
CHAPTER 05Maintain traceable quality recordsKeep technical and quality records identifiable, retrievable and protected against uncontrolled changes. Link complaints and…
Keep technical and quality records identifiable, retrievable and protected against uncontrolled changes. Link complaints and nonconformities to investigations and corrective actions. Staff should know how to escalate issues that may require regulatory evaluation.
CHAPTER 06Prepare an effective assessmentUse internal audits and management review to examine implementation across the agreed scope. An independent certification body…
Use internal audits and management review to examine implementation across the agreed scope. An independent certification body performs the certification assessment. We support gap analysis, documentation and corrective action planning while the business retains its regulatory responsibilities.
No matching topics
Try “testing”, “documents” or “process”.
Official sources & further reading
ISO — ISO 13485:2016 ISO — Medical device quality management overview ISO — Certification and choosing a certification bodyRequirements depend on the scope, sites and programme. Confirm the applicable standard, assessment route and current scheme rules before proceeding.
05 / A LITTLE MORE CLARITY
Your questions.
Our starting points.
Practical answers to common questions about ISO 13485 Medical Device Quality.
01Does ISO 13485 certify the medical device itself?
No. It concerns the organization’s quality management system. Device-specific regulatory requirements must be assessed separately.
02Can suppliers and service organizations use it?
Yes, where the standard is applicable to their role in the medical device supply chain and the defined system scope.
03Can an ISO 9001 system simply be renamed?
No. Medical device activities and regulatory purposes require a specific gap assessment and appropriate implementation.
04What should be prepared first?
Start with the organization’s role, device or service scope, process map and target market obligations before developing detailed documentation.
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LET’S PLAN WHAT’S NEXT
Your business.
A world of potential.
Turn your project details and ambitions into a clear starting point.
Create my project briefService marks and organization names identify the standards and regulatory topics discussed. They do not indicate certification of, affiliation with, or endorsement of Complise Global.