As a medical device company, your Quality Management System is the backbone that ensures that your medical devices remain safe, effective and compliant with all applicable regulations. At Bannick, we help medical device companies align their Quality Management System with industry standards, market regulations and business needs. We understand the importance of purpose-driven implementation of your Quality Management System, avoiding potential noncompliance with ‘one size fits all’ approaches. To achieve operational efficiency and ensure that you have a complaint system that helps you meet your business needs, it is important to have a risk-based, right sized system.
Key elements that often get overlooked include Document Control and procedures.
- Does your current Quality System comply with 21 CFR 820.40 Subpart D – Document Controls and ISO 13486:2016?
- Is your Document Control system reviewed annually to ensure that the Quality System is maintained in accordance with regulations and continues to meet the requirements of the company?
- Do your documents, such as Standard Operating Procedures or Work Instructions, effectively describe the purpose, steps and requirements for specific activities or processes?
Whether you need a review of your existing documents, creation of new documents or a total system re-design, Bannick LLC is your experienced QMS partner. Our Quality services are tailored to help you achieve your goals. Contact us to learn more.