Every member of your organization should approach their work with regulatory compliance in mind. This mindset will help them identify and respond to issues proactively and at low cost, as issues can be remedied wherever they arise—before their effects become consequential.
Invest in employee training for:
Kapstone can help your team be prepared and competent for all of these topics and can tailor training as much as needed to be effective for your team. We’re flexible to providing training sessions as short as a half day to as long as on-going periodic touch points. We can offer coaching or mentor style opportunities best suited for your personnel.
We’ll work together with your team to ensure compliance with ISO 13485:2016, the most relevant international regulatory standard for medical device companies. We train companies on how to devise a quality manual, what to include in a medical device file, how to handle document control and medical device recording, ongoing management responsibilities, and more.
The European Union Medical Device Regulation (MDR) governs the activities of all medical device companies looking to commercialize their products in the EU. As the MDR adaptation continues to evolve and be implemented, your organization will have to follow suit. Kapstone is prepared to educate your team on the latest MDR developments, working across your various functions to institute a culture of compliance and excellence.
Though the FDA has the right to inspect your organization and its procedures without notice, you can prepare for those inspections by investing in quality system regulation (QSR) training for your team members in any resource department. This training will help them identify and respond to nonconformities, document them appropriately, and altogether ensure compliance—and successful inspections.
You know that risk management is a core responsibility for medical device companies. But do you know exactly what goes into effective and efficient risk management? Is your team properly educated on how to implement your risk management strategies?
Risk management training helps your organization and its employees proactively evaluate risk in the right mindset, taking all potential hazards and risks into account.
CAPA, or Corrective and Preventive Action, procedures are an important part of regulatory compliance. Under CAPA requirements, your organization is responsible for creating and maintaining procedures that:
Effective CAPA procedures require constant input from most, if not all, of your team members. We can help you train them to recognize, report on, and remedy nonconformities.
Regular audits are essential to ensuring that your protocols are functioning as expected and that your team is following procedures as stated in your quality system. However, audits can be quite complicated—particularly for employees who have never conducted them before, or who don’t understand your organization’s quality standards.
Internal audit training brings your employees up to speed on every part of auditing: observation, measurement, evaluation, and recommendations for improvement. Committing to excellence in your internal auditing is the best way to prepare for consequential external evaluations.