ISO 13485 Certification
Core Compliance takes the headaches for Medical Device companies looking to obtain ISO 13485 Certification, FDA Compliance, with providing expertise for 510k submission and CE Marking. We build a custom quality management system that fits and benefits your organization, rather than just creating more documentation and work. Core Compliance has offices on the west coast and east coast to meet with your organization.
We can help you achieve ISO 13485 certification in as little as 60-90 days. And, we offer both on-site and remote consulting that is flexible enough to fit your schedule and efficient enough to meet your timeline and budget.
Start the ISO 13485 Certification process
ISO 13485:2016 Medical Devices- Quality Management System
ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) related to medical devices. This standard outlines the requirements related to quality management for an organizations’ need to demonstrate its ability to provide medical devices and related services that consistently meet customer’s and regulatory FDA requirements.
Core Compliance provides a clear Road Map for ISO 13485 Certification FDA Compliance
ISO 13485:2016 certification is a two-part process,
First, we (Core Compliance) guide companies in the development of a 21cfr part 820 (Medical Devices) Quality System Regulation system that aligns with medical device internal processes and procedures, while also achieving compliance with FDA. We guide your med-device company through the FDA 510K pre-market US submission and set up CE Marketing.
Second, a certification body, also referred to as a “registrar”, performs an audit to assess compliance with the standard and the organization’s declared management system. Upon a successful audit, the organization is granted a certificate of compliance from the trusted third party registrar. The organization undergoes additional but lesser surveillance audits at least annually thereafter for 3 years until the certification then expires and requires a re-certification.
Looking for another ISO Certification?
Core Compliance has expertise in the following ISO standards:
ISO 9001:2015 –Quality Management Systems
ISO 13485:2016 FDA Compliance 510K Submission CE Marking –Medical Devices Quality Management Systems
ISO 17025–Testing & Collaboration Laboratories Management
AS 9100–Aerospace Industry Quality Management Systems
ISO/IEC 20000:2011–Information Technology Service Management
ISO/IEC 27001:2011–Information Technology Security Management
R2:2013 RIOS Electronics Recycling NAID –Information Destruction e-Stewards –Responsible Recycling and Reuse of Electronics
ISO 14001– Environmental Management Systems
OHSAS 18001 ISO 45001 –Occupational Health & Safety Management
ISO/TS 16949-Automotive Industry Quality Management Systems
Understanding ISO 13485 Certification: A Pathway to Excellence in Medical Devices
ISO 13485 Certification is a crucial benchmark for medical device companies focused on meeting rigorous quality and regulatory standards. As a globally recognized standard, ISO 13485 Certification outlines the critical requirements for a quality management system (QMS) specifically designed for the medical device industry. This certification is not just about compliance; it’s about demonstrating a company’s dedication to quality and customer satisfaction.
Why ISOCompliance 13485 Certification Matters
ISO 13485 Certification is vital for medical device manufacturers. It provides a structured framework for a robust QMS, ensuring consistent design, production, installation, and servicing of medical devices that meet both customer and regulatory needs. Globally recognized, ISO 13485 Certification is required by regulatory authorities like the FDA and is integral for CE marking in Europe.
The Certification Process and Its Advantages
- Step-by-step Alignment: The process of obtaining ISO 13485 Certification involves aligning your company’s operations with the standard’s requirements. It includes developing a QMS that complements existing processes, minimizing disruptions, and maximizing compliance.
- Core Compliance Expertise: Companies like Core Compliance offer expert guidance, assisting organizations through tailored on-site and remote consulting services.
- Benefits: ISO 13485 Certification boosts product quality and safety, reduces regulatory risks, and fosters continuous improvement, enhancing customer satisfaction.
Aligning with FDA Requirements and CE Marking
ISO 13485 Certification aligns with FDA regulations, specifically 21 CFR Part 820, insuring companies are prepared for FDA inspections and 510k submissions. Additionally, it facilitates CE marking for devices in the European Economic Area, signifying compliance with EU safety, health, and environmental standards.
The Role of a Quality Management System
A QMS under ISO 13485 Certification provides a systematic approach to managing processes, ensuring high-quality product output. It aids in risk identification, documentation management, and corrective action implementation, ensuring products exceed regulatory and customer expectations.
Core Compliance: Your Certification Partner
Navigating ISO 13485 Certification can be complex, but Core Compliance offers invaluable support. Their expertise in regulatory submissions, including 510k and CE marking, provides a clear certification roadmap. Their flexible services cater to various schedules and budgets, with ISO 13485 Certification achievable in 60-90 days.
Conclusion: The Strategic Investment in Quality
ISO 13485 Certification is more than a regulatory hurdle; it’s a strategic investment in excellence and customer satisfaction. Implementing a robust QMS through ISO 13485 Certification ensures product quality and safety, building trust and loyalty among customers. As the industry evolves, ISO 13485 Certification remains essential for innovation and compliance, driving the future of medical device manufacturing.
Call to Action
Ready to elevate your medical device company’s quality and compliance? Explore the benefits of ISO 13485 Certification with expert guidance from Core Compliance. Contact us today to start your pathway to certification excellence.
