medicQA aims to support medical device companies in establishing the necessary regulatory and quality framework around the activities of product development, manufacturing and marketing. We offer a wide range strategic solutions customized to best suit the needs of our customers.
Quality Management System Establishment
Our many years of experience in the medical device industry have allowed us to construct a robust framework for a Quality Management System compliant to a range of regulatory requirements. This framework has been successfully adapted to a number of companies and is continually evolving with new regulations in the field. medicQA does not believe in forcing a standard solution on a company, we always work towards building a Quality Management System that fits your specific needs. Through our collaborative approach and workshop-oriented training style, we ensure that your employees become familiar with the Quality Management System from the start.
We know the medical device industry from the inside out and understand that a Quality Management System with complicated requirements and unnecessary administrative steps only lead to employee frustration and audit nonconformance. We build Quality Management Systems that are easy to understand and easy to use, while still complying with regulations.
A medical device development project may involve a Notified Body, third party test house, and one or more development or manufacturing subcontractors. Ensuring that all of these stakeholders are receiving the information they need to contribute to the progress of the project can be time-consuming. Similarly, it can be difficult to get an overview of the customer and regulatory requirements facing an innovative medical device. However, these issues can be the key to successfully bringing a device to market within the constraints of time and budgets.
medicQA’s project managers have years of experience in handling the complex requirements of medical device development projects and ensuring that projects are completed successfully, on time and on budget. Whether you need project management for just a critical phase or subproject, or for the entire development period, our project managers insulate the team from distractions and allow them to focus on developing the device.
Regulatory Affairs Management
medicQA offers the development of a complete regulatory strategy for your device, including device classification, overview of applicable regulatory requirements, and a list of documentation deliverables for a market approval submission.
We can tailor our involvement in the construction of technical documentation for market approval to the needs of your company. Experienced consultants at medicQA can review your documentation prior to submission and provide constructive feedback to ensure the best possible chances of approval. We can also provide integrated support throughout the design process to write key documents such as the Risk Management Report, design specifications, and usability specifications in collaboration with the design team.
Quality Management System Maintenance
All medicQA consultants are trained lead auditors who are proficient in organizing and executing an internal audit program for your company. With a medicQA auditor, you can rely on a thorough and constructive assessment. We can further support you through the certification process by performing mock audits to prepare company employees and by participating in external audits to ensure expert back-up in a critical situation.
We at medicQA can also support supplier management tasks, such as searching for alternative suppliers, qualifying new suppliers, and developing the quality of existing suppliers.
Complaints and corrective and preventive actions are critical processes which are subject to significant scrutiny from auditors and inspectors. medicQA can assign a consultant to manage these processes in your company, assuring that complaints and corrective and preventive actions are adequately documented and closed in a timely manner.
medicQA offers high flexibility in terms of its involvement with your project . We can establish and maintain your QMS, but you can also decide to only involve us for specific tasks or for a limited time period, e.g. during a critical phase of your project. This is all up to you to decide.