ISO 13485 Certification Consulting for Medical Device and IVD manufacturers
We guide you through every step of implementing and maintaining ISO 13485
Why ISO 13485 Certification matters
Why ISO 13485 Certification matters
ISO 13485 is a Quality Management standard for medical device and in vitro diagnostics industries. It applies to companies who are engaged in Design, manufacturing, installation, Servicing and or distribution of medical devices and IVDs.
Many global jurisdictions either require ISO 13485:2016 certification or strongly recognize it as evidence of compliance. If your organization plays any role in the lifecycle of medical devices or IVDs or in supporting its manufacture, use, or maintenance, ISO 13485 certification is either mandatory or recommended.
Achieving and maintaining certification matters. It ensures consistent safety, quality and regulatory compliance and facilitates market access in regulated regions (EU, USA, Canada, Australia, etc.).
We guide you through every step of implementing and maintaining your ISO 13485 based QMS. Our consultants bring hands-on experience from notified bodies and know industry best practices. They deliver a tailored QMS that fits your existing processes. From experience we know no QMS is the same. It needs a tailored approach, to meet your business needs. Whether you’re starting from scratch, upgrading an existing Quality Management system, or preparing for successful certification or re-certification, we help you achieve your goals without compromising efficiency or innovation.
Satisfied Clients
Our ISO 13485 Consulting Services:
QMS Design and Implementation
We build or adapt your quality management system, its policy, procedures, and work instructions to ensure full compliance with ISO 13485, aligning it with MDR, IVDR, or FDA QMSR requirements.
Gap Assessments
We assess your current Quality System against ISO 13485:2016 standard and additional country specific requirements if needed. We identify missing elements, inefficiencies, or inconsistencies that could lead to audit findings. We provide recommendations for improvements.
QMS Optimization and eQMS implementation
We streamline your processes, simplify regulatory compliance and maintaining flexibility for your business growth. We also support the implementation of your digital QMS to allow for a robust foundation to maintain compliance.
Internal Audit and Certification Preparation
We prepare your teams for audits, conduct pre-certification reviews, perform internal - or supplier audits and ensure your documentation and processes are audit-ready.
Post-Certification Support
We help you maintain ongoing compliance through regular health checks, internal audit and training.
Our practical approach turns ISO 13485 certification into a business advantage. We align quality management with your strategic goals, creating systems that add value, prevent compliance gaps, and prepare you for any third party audit.
Couldn't find your question?
Do I need ISO 13485 certification to market my device?
While not always mandatory, ISO 13485 certification is required by many regulators and customers and is a cornerstone for CE marking, MDSAP, and global market access.
How long does it take to implement an ISO 13485 QMS?
Implementation typically takes three to six months, depending on company size, resources, and the complexity of your operations.
Can you help us integrate ISO 13485 with MDR, IVDR, or FDA requirements?
Yes. Our consultants specialize in harmonizing ISO 13485 systems with MDR, IVDR, and QSR frameworks for global compliance.
What if we already have certification but need improvement?
We offer QMS optimization, internal audits, and training to enhance existing systems, close audit findings, and ensure continued certification readiness.