More Than a License to Operate: Certification Facilitates Business Improvement
Organizations that view certification as a "necessary evil" are missing the bigger picture: assurance processes and services can deliver to the bottom line.Read More
Medical Devices Industry Standards
Advance your medical device development through targeted management systems certification that supports innovation and quality.
Medical Device Industry Standards Overview
Meet the regulatory requirements essential for medical device manufacturers and their suppliers.
Certification Journey
Our straightforward process for helping you to achieve medical devices industry certifications can be completed in these simple steps.
Certification Preparation
We get to know your organization, its processes, and proposed scope of certification. This may require informational meetings, as well as your application, offer and contract before planning your Stage 1 Audit.
Readiness Assessment
We perform and document your Stage 1 Audit, then create a report identifying areas of concern along with a decision about the organization’s readiness to proceed to Stage 2 and the best timeline. We will send you a report so there are no surprises.
Auditing
Our Stage 2 Audit is a management system assessment against the requirements of the standard(s) and the organization’s own implemented management system. We will share our assessment report with you, detailing any nonconformities and the timelines required for corrective action implementation and verification. We will thoroughly evaluate corrective measures taken to verify their effectiveness and whether or not the management system meets the minimum requirements for becoming certified.
Certificate Issuance
Once all requirements have been met, you will receive your certification, which is typically valid for three years. Afterward, periodic surveillance audits are conducted, to ensure ongoing conformity of the management system, compliance with relevant interested party requirements and continuous improvement of the management system(s). The certification cycle is a 3-year period, and continued certification requires a renewal at the 3-year mark.
Benefits of Medical Device Industry Standards Certifications
Achieving and maintaining compliance positions your company needs to meet your near-term goals and customer contract requirements, and actively identify areas for improvement.
Brand Reputation
Companies that prioritize product quality and operational safety can readily differentiate themselves from the competition.
Regulatory Compliance
Certifying your management systems and processes can help you achieve compliance and reduce risk to regulatory concern.
Cost Savings
From lowering operating costs to protecting the supply chain, companies can better plan for long-term success.
ABS QE Services
Certification Services
Eliminate uncertainty in your operations with a leading, globally trusted partner known for developing solutions that assist with complex challenges.
Training Services
Gain the knowledge and skills necessary to improve operational efficiency and effectiveness, as well as assist with regulatory compliance.
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