Quality assurance services include identifying quality metrics, ensuring continuous improvements, and aligning with your business needs and objectives. Medical device subsystem consultants are experienced in quality needs of all different sizes of companies. These medical device consultants know how to establish, maintain and improve quality, and specialize in applying this knowledge to your organization.
In the medical device industry, Quality assurance (QA) is more than just ensuring the quality of a finished product. Because the device has entered the marketplace, you need tools to monitor and control every process, from the original design of the new product to continued quality compliance. Regulatory experts, such as the Biotech Research Group, provide the help needed to monitor these processes and ensure quality compliance at every step.
Outsourced Quality Support
The medical device industry faces increased challenges as companies move into the QA world with fewer employees, especially in the cse of more sophisticated devices. Strategic planning and guidance is essential to developing a quality management system, but this requires the time and effort of many dedicated and staff.
Many times, outsourced quality support services are a great solution to this challenge. Consultants, like BIOTECH RESEARCH GROUP, can meet a variety of needs throughout a product’s life cycle, provide reliable and up-to-date expertise, and save money on hiring home staff. They can help in situations such as:
● Growth or changes in staff
● Special projects
● Delegation of QA duties
● A new company that need QA insights
● Medical Device Single Audit Program (MDSAP) preparation
Services such as those provided by BIOTECH RESEARCH GROUP can help you navigate the required functions as you address you quality systems or prepare for an MDSAP audit.
When you need to meet a deadline to meet ISO requirements, consultants can help medical device companies get the job done. They offer services including:
● Quality system modification and implementation
● Quality system interval estimates
● Readiness audits
● Risk Management (ISO 14971)