Medical Device Quality Assurance

1. Types of Quality Assurance

1.1. ISO 13485

1.1.1. The inspection and traceability for implantable devices

1.1.2. Requirements for sterile medical devices

1.1.3. Product cleanliness and contamination control

1.2. ISO14971

1.2.1. Review a product’s intended use

1.2.2. Identify and quantify any potential hazards during the design and development process

1.2.3. Mitigate risks to a acceptable level and affirm the acceptability of risk prior to marketing a device

1.2.4. Establish processes to monitor products post market and take action if risks are greater than expected or new risks arise

1.3. FDA

1.3.1. Complaint Handling and Corrective and Preventive Action (CAPA) programs

1.3.2. Design control, including risk management and design validation

1.3.3. Document control systems

1.3.4. Software quality assurance programs

1.3.5. Process validation

2. Person Goals

2.1. Complete Finance/German degrees

2.2. Begin work for Comapny in German (possible offer)

2.3. Get CE and ISO Certified

2.4. Progress into International Quality assurance and Compliance

3. Reasons for Quality Assurance

3.1. Prevent Mistakes

3.2. Prevent Defects

3.3. Optimization

4. QA Audits

4.1. Gap Assessment

4.2. Pre-Certification Audits

4.3. Internal Audits

4.4. Subcontractor/Supplies Audit

4.5. Due Diligence Audits