Quality assurance services include identifying quality metrics, identifying quality metrics, ensuring continuous improvement, and aligning with your business needs and objectives. Their Medical device subsystem consultants are experienced in quality companies and major companies and start-ups. They know how to achieve, maintain and improve quality, and they specialize in transferring this knowledge to your organization.
In the medical devices industry, Quality assurance (QA) is more than just ensuring the quality of a finished product. Because the device is being marketed, you need tools to monitor and control every process, from the design of a new product to continuous quality compliance. At BIOTECH RESEARCH GROUP, they provide you with the help you need to monitor these processes and ensure quality compliance at every stage.
With over 15 years of experience as a trusted Medical device quality consulting, their more than 500 professionals and FDA players are fully equipped to handle your unique QA needs. They offer the accompanying administrations intended to assist you with adjusting your quality administration rehearses.
Outsourced Quality Support
The medical device industry faces increased challenges as companies move into the QA world with fewer employees. Strategic leadership is essential to developing a quality management system, but this leadership requires the time and effort of many dedicated and unaffordable staff.
Outsourced quality support services are a great solution to this challenge. BIOTECH RESEARCH GROUP can meet a variety of needs throughout your company’s life cycle, which will provide you with reliable expertise, while saving you money on hiring home staff. They help in situations such as
● Multiplication or changes in staff
● Projects Special projects
● A strategic management and leadership of QA duties
● A new company that need a QA insight
● Medical Device Single Audit Program (MDSAP)
BIOTECH RESEARCH GROUP can help you navigate the required functions as you prepare for an MDSAP audit. They offer MDSAP-based administrations to help you in the accompanying territories:
● MD Interval assessments to assess MDSAP requirement compliance
● S System upgrades to help you switch to MDSAP
● Product support and duplicate audits for the rigorous MDSAP audit process ISO 13485
When you meet a restricted deadline to meet ISO 13485 requirements, BIOTECH RESEARCH GROUP’s Quality Assurance Specialists are here to help your medical device company get the job done. They offer services including:
● Quality system modification and implementation
● Quality system interval estimates
● Readiness audit
● Management Risk Management (ISO 14971)