Quality Assurance
End-to-end QA support, including seamless Quality Management System (QMS) implementation, hands-on Quality Assurance support, and auditing services.
Embedding quality into daily operations
As a MD or IVD manufacturer you must comply with multiple, often changing, regulatory frameworks. Keeping up with updates and aligning internal processes is a constant challenge. Many companies struggle with a QMS that is either too rigid or too informal, making it hard to scale or pass audits.
At Qserve, we bring together a team of seasoned consultants with hands-on experience in both the medical device industry and regulatory bodies. Whether you're a startup building your first QMS or an established company preparing for certification, we work alongside your internal teams to embed quality into your daily operations.
Our quality assurance cover multiple disciplines. Discover all of them
QA support
Do you need help with CAPA, risk management, or post-market surveillance? Our consultants are ready to step in where and when you need them most.
Interim Support
Vacancies in key Quality Assurance roles and understaffing can disrupt operations and delay compliance milestones. That’s why we provide interim QA management services: experienced professionals who can step in quickly and keep your quality systems running smoothly.
Audits and Assessments
We can perform internal, supplier, mock audits, or QMS GAP assessments. GAP assessments and reviews of your technical documentation support your business goals.
Training
We offer training, designed to strengthen your team’s QA capabilities and ensure compliance with global regulatory standards. Whether you're onboarding new staff, preparing for audits, or building auditing skills, our training can be tailored to your needs.
Mergers & Acquisitions
We understand the high stakes and acquisition processes, and address potential regulatory risks related to products and markets.
QA services help you to meet and maintain regulatory requirements across global markets. Search for structured, hands-on support to avoid costly delays, nonconformities or safety issues by embedding quality awareness and continuous improvement into every stage of your operations.
At Qserve, we follow a structured and practical approach, starting with understanding your business and regulatory landscape. Our team with hands-on QA experience in both the medical device industry and regulatory bodies brings a unique perspective offering practical support tailored to your specific needs.
At Qserve, we follow a structured and practical approach, starting with understanding your business and regulatory landscape. Our team with hands-on QA experience in both the medical device industry and regulatory bodies brings a unique perspective offering practical support tailored to your specific needs.
