Quality Assurance

Medical Device Quality Assurance

Regulatory Compliance Associates (RCA^®) Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics. Our quality consultant projects are designed to ensure continuous improvement and align with your business needs & goals. Our quality consultants are quality experts with experience spanning major corporations and start-ups. Our quality management consultant team knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates, we offer you the quality control consultant assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and regulatory veterans is fully equipped to handle your unique QA needs. We offer the following quality consultant services designed to help you align your quality management practices:

Outsourced Quality Support

The medical device industry faces increased challenges as companies navigate the world of QA with fewer personnel. Strategic leadership is necessary for creating a quality management system, but this leadership requires a dedicated staff that many companies can’t afford. Outsourced quality support services are an ideal solution to this challenge. Regulatory Compliance Associates can meet a variety of needs throughout your company’s life cycle that will give you trusted expertise while saving you the money of hiring in-house staff. We will assist in situations such as:

Short-term augmentation due to transitions in staff:
- Quality Assurance Consultant
- Quality Control Consultant
- Quality Engineering Consultant
- Quality Management Consultant
- Quality Systems Consultant
- Software QA Consultant
- Software Quality Assurance Consultant
Special projects
Strategic management and leadership of QA duties
New companies in need of QA insights
Root cause investigation
Corrective and preventive action support
Complaint handling
Recall management

Medical Device Single Audit Program (MDSAP)

Regulatory Compliance Associates will help you navigate required activities as you prepare for an MDSAP audit. We offer MDSAP-based medical device quality consultant services to support you in the following areas:

Gap assessments to evaluate MDSAP requirement compliance
System improvements to assist with the transition to MDSAP
Preparation assistance and mock audits for the rigorous MDSAP audit process

ISO 13485

When you face restrictive deadlines to meet ISO 13485 requirements, Regulatory Compliance Associates quality assurance specialists are here. Our quality management system consultant team offers the following services, including:

Quality system transition and implementation
Quality system gap assessments
Readiness audits
Risk management (ISO 14971)

Contact Regulatory Compliance Associates for Quality Consulting

Regulatory Compliance Associates has been the go-to choice of thousands of life science companies around the world for top-quality QA services. We offer the chance for both small and large businesses to seamlessly implement and regulate QA practices, overcome industry challenges and flourish under FDA scrutiny.

We know just how deeply a quality assurance crisis can impact your business for years to come. Let us help you avoid these challenges through our industry-leading quality assurance consulting services. We specialize in QMS consultant support that is customized to meet your unique and evolving business needs.

About Regulatory Compliance Associates

Regulatory Compliance Associates (RCA^®) provides healthcare consulting to the following industries for the resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

Founded in 2000
Expertise backed by over 500 industry subject matter experts
Acquired by Sotera Health in 2021

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

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