Looking to get 13485 certification?

Getting overwhelmed with FDA requirements?

Trying to find internal resources to implement ISO 13485 QMS?

Looking for Medical Device 510K CE Marking?

Core Compliance creates a clear path to ISO 13485 FDA compliance

ISO 13485 Certification

https://www.youtube.com/watch?v=PP37Vgy-MCs

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

CLICK HERE ISO 13485 Consultation

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