I) 21 CFR PART 820
As a medical device consultant, RT PRO can assist your company in meeting the requirements of 21 CFR Part 820, which outlines the quality system regulations for medical devices.
How RT pro can help?
1. Regulation interpretation: RT PRO will assist your business in comprehending 21 CFR Part 820’s obligations and determining how to implement them.
2. Evaluations of compliance: RT PRO can thoroughly examine your company’s quality system to see if it complies with 21 CFR Part 820 regulations.
3. Gap analysis: RT PRO can pinpoint areas where a business’ quality system falls short of 21 CFR Part 820 specifications and offer advice on how to close such gaps.
4. Process improvement: RT PRO can assist a business in enhancing its quality system procedures, including process validation, design controls, and risk management, to comply with 21 CFR Part 820 criteria.
5. Audit preparation: RT PRO will arrange dummy audits and advise on handling any results. As a consultant, we can assist a business in getting ready for FDA inspections and audits.
How RT pro can help?
1. Standard interpretation: RT PRO can assist businesses in understanding the criteria of the ISO 13485 standard and how they apply to their organization
2. Gap analysis: RT PRO experts team consultants can point out places where a business’ quality management system falls short of ISO 13485 requirements and offer advice on how to fill such gaps.
3. Compliance evaluations: RT PRO will extensively study the system to ensure your business meets ISO 13485 requirements.
4. Process improvement: RT PRO can assist your business in enhancing its quality management system procedures, including process validation, design controls, and risk management, to satisfy the standards of the ISO 13485 standard.
ii) ISO 13485
RT PRO can assist a company seeking to comply with the ISO 13485 standard, an international standard for quality management systems specific to medical devices.