QUALITY ASSURANCE & COMPLIANCE
Proven risk-based methodologies grounded in a quality-first mindset enable clients to meet quality assurance and compliance requirements based on the complexity of their medical devices.
QUALITY ASSURANCE and COMPLIANCE ARE ESSENTIAL FOR MEETING CUSTOMER NEEDS AND REGULATORY REQUIREMENTS
Our disciplined thinking and comprehensive approach to QA engineering emphasizes QMS methodologies honed over decades working in the MedTech industry. This combination results in improved project predictability, regulatory compliance, and safe and effective products every time.
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QMS Compliance Gap Analysis
Do your procedures meet the FDA QSR and ISO 13485 requirements? Do your procedures comply with ISO 14971, IEC 62304 and IEC 62366 standards?
Quality Management Systems are key to demonstrating compliance with the demanding regulations and standards inherent in MedTech development.
Our proprietary compliance gap analysis process can quickly identify the state of your QMS relative to these strict standards. At the conclusion of an audit, clients receive a comprehensive gap analysis report detailing each issue along with corresponding recommendations and insights to remediate identified concerns.
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QMS Compliance Remediation
What’s the state of your QMS?
QMS compliance is essential for organizations to ensure that their products or services meet the required quality and regulatory standards, satisfy customer requirements and achieve their business objectives. Any number of adverse events can trigger the need for QMS compliance remediation.
Whether you have identified the non-compliance issue and need help correcting it, or need a full audit of your QMS to identify non-compliance issues, our team of Quality Assurance experts design and implement remediation plans. Our aim is to help organizations achieve regulatory compliance, improve quality performance, increase efficiency and productivity, and manage risk.
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Quality Assurance Engineering
How do you effectively identify process and compliance issues, and are you equipped to successfully address them?
Our experienced Quality Assurance teams engage and collaborate with clients to identify and address process and compliance concerns. With a collaborative approach, we act as project participants, seamlessly developing and implementing new processes, or diligently remediating compliance issues.
With an unwavering focus on a singular goal, we strive to ensure that our clients consistently deliver products that are not only safe and secure but also highly reliable, meeting all necessary regulatory standards. Our unwavering commitment to quality and compliance empowers our clients to build trust, maintain credibility, and achieve long-term success.
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Computer Software Assurance / Software Tool Validation
How are you preparing to demonstrate and document that your software tools meet the computer software assurance guidelines for compliance and quality management?
With regulatory scrutiny now extending beyond the end product to the tools used during the entire product lifecycle, tool validation is critical to your development, manufacturing, and overall business processes. Unfortunately, tool validation is often overlooked or misinterpreted due to inexperience or resource constraints, leading to additional effort at the end of a project.
Our experience validating hundreds of software tools informs our risked-based approach, allowing us to quickly engage on a computer software assurance project to ensure clients effectively manage product and business risk. Keep your team focused on core product development activities and let us remove doubt and uncertainty about the state of your software tools.
“We could not have finished our three software releases without MedAcuity quality engineering support. They led by example and improved not just our product but our processes.”
Director of Software Development | Life Sciences technology company