Process Quality Consulting (PQC) is a vital resource in providing quality and regulatory services for medical device firms and startups. PQC is an affordable, reliable, and results oriented consultancy with focus on compliance and efficiency. PQC expertise includes:
Creating nimbleness in Quality Management Systems (QMS) while maintaining compliance to regulatory requirements is what startups and small device firms need to do in order to be competitive. Process Quality Consulting can build your QMS from the ground up. Whether built from a software driven QMS or from MS Office based system, PQC can create and install your system with all elements: Complaints, CAPA, Inspection, Document Control, Material Management, Supplier Selection, Auditing and Controls, Internal Audits, Management Review, Risk Management, Design Controls, CE Marking, Post Market Surveillance, and all the remaining elements of an effective QMS.
Management: Medical Device Startups and small firms are many times resource-starved or they are early in their development or marketing phases and cannot utilize a full-time Quality Manager. Process Quality Consulting manages quality systems for startups and small medical device companies seeking to maximize resource usage and minimize the bottom line. Part-time quality management by PQC provides the ideal balances for these types of situations.
A key part of the design control process is risk management. Not only is it a compliance element, but an important tool in understanding and maintaining the safety and efficacy of the product.
Process Quality Consulting can lead the risk management process, including working with key personnel to create a risk analysis that is not overly burdensome but is user friendly and is helpful in assisting the design process in achieving a safe and effective product. Defining failure modes, both design and process, and helping innovators working out appropriate design features and mitigations is our priority.
Having an effective internal audit process to satisfy the quality audit regulatory requirements can be a challenge for a small firm or startup. For both cases, having sufficient resources to perform the audit is always a concern, and providing independence and an unbiased review is imperative for the audit to be successful. PQC provides options here. You may want an internal auditor, or you may want to take advantage of our Internal Audit Manager service, which includes audit management, scheduling, and follow-up.
PQC provides support for IEC 60601-1 Product Safety testing and approval. Compliance to the IEC 60601-1 International series of safety standards may be needed in order to receive domestic or foreign regulatory product approval. PQC can help navigate through these standards, through safety agency requirements, around CB protocols, and work with test facilities to achieve the approval(s) required. PQC will help you understand the particular and collateral standards that apply to your product for the intended markets and the labeling and marking requirements that apply to your product.
CE Marking is required for medical devices to be marketed in the European Community. For most devices, a Technical File is a major requirement to obtain CE Mark. The Technical File is a synopsis of how the device meets the safety and performance expectations and answers the many Essential Requirements questions of the Medical Device Directive.
The mission of PQC is to assist medical device startups and innovators with an efficient, effective, and compliant quality system. Our desire is to help our clients get new medical devices into clinical environments sooner in order to benefit patients and society earlier. Along with this, our desire is to assist our clients design and manufacture high quality, highly effective and safe products for enhanced patient and user satisfaction and better health.
