Regulatory Compliance is the appropriate application of regulatory requirements to a Quality Management System (QMS) and the operations of medical device company. Our knowledge of regulations and standards helps shape and maintain your system. We can also conduct a gap analysis when regulations and standards change and help your company adapt in the least painful manner.
We have extensive experience in registering medical devices in key global markets. US marketing required different FDA notification based on the risk and novelty of a device. Most Class I devices still require listing with the FDA and application of current Good Manufacturing Practices (cGMP's) including documentation of the design and manufacturing of the device. More complicated devices will require either premarket notification through a 510(k) or premarket approval (PMA). Our team will help strategize the best path for clearance and guide you through the submissions and responses as questions arise.
Marketing in Europe requires the gathering of documentation of the device family into a Technical File or Design Dossier, again depending on the risk and classification of the product. The higher level class products will require certification of both the device's Technical File and the proper application of your quality system to meet the Essential Requirements according to the Medical Device Directive.
The certification of your Quality Management System and approval of your product for CE marking is done through a Notified Body (NB). The NB will conduct an audit of your QMS and, where appropriate, your Technical File or Design Dossier. Minier MDC has extensive experience in working with the major NB's and can guide you through the process.
The NB will conduct annual audits, quality system recertification audits every three years, and now are required to conduct unannounced audits. Our team has been through all three and can respond quickly to help you through the audits and address any non-conformities found through well documented corrective actions.
The issuing of the revised Medical Requirements means that medical device manufacturers will again be revising their quality system to meet these. Our group can help target your efforts to most efficiently step up to meeting these requirements.
Our experience also extends to product licensing in Canada and registration in Japan, Australia, Brazil, China, and Russia. Contact us for more information if you are considering expanding into these markets.
The European Union will be phasing out the MDD, Medical Device Directive, and implementing the MDR, Medical Device Regulation. The MDR has significant changes which result in increased requirements and visibility for all medical devices. Smart companies, importers, exporters, and distributors are preparing now for these new challenges.
At a glance changes for medical devices to meet the new MDR requirements include:
Our team will work with your product experts to create a thorough evaluation report that will satisfy regulatory requirements while staying on target and within budget.
MEDDEV 2.7.1 rev 4
With MEDEV 2.7.1 rev 4 there significant changes to the requirements for Clinical Evaluation Reports (CER) include increased clinical data requirements, new requirements for Class I devices, . While postmarket clinical follow up is beneficial, a well constructed CER can justify the use of preclinical testing, literature evaluation, and postmarket surveillance.
Manufacturers have another year and a half to step up to the added requirements of ISO 13485. This revised standard is more risk based and specifies more validations and verification. Call to discuss a gap analysis or audit to find out where you can make the most of your existing quality system with small changes to comply with the new standard.
Quality Assurance planning
Quality Assurance Planning - Good Quality Assurance does not just happen. It is planned. We will help you plan your Quality Management System to function smoothly so that it becomes a true asset that your personnel utilize daily. Our experience will evaluate your QMS and help you create a step by step plan to implement a full system that includes design control, purchasing, training, process validation, document control, training, and all other elements of a first rate Quality Management System.
Quality Management System setup
Your Quality Policy sets the tone of what you want to do with quality and regulatory requirements within your company. The Quality Manual details how you will create a culture of quality as you grow. This document becomes your declaration of the processes you will follow and how your quality system will function as a whole. It starts with how you will meet the basic requirements for a quality system through management responsibility and your personnel. It identifies how you will control product design, control documents, control purchasing, control production and processes. On the quality control side it identifies how you will inspect incoming materials, work in progress, and finished product. It states how you will control non-conforming product and take corrective and preventive actions. It states how you will control records and documents such as device master records, quality system records, and complaint files. It states how you will monitor your quality system and use early detection to catch potential problems.
SOP's and Work Instruction review/revision
Standard Operating Procedures (SOP's), also called Standard Procedures (SP's), or General Procedures (GP's), give more detail for overall goals and high level requirements for each area covered by your Quality Assurance System. This is often where an auditor finds non-conformances. We can help by conducting an internal audit to find and help find issues before the external audit. We then help you either correct your process or modify the SOP so you "do what you say and say what you do" while still meeting regulatory requirements and standards to which your company claims conformance.
Regular Internal Audits are not only a good idea, and they are not only required, but they can be a great source of assuring yourself and your customers that you are producing excellent products. Our auditors are experienced and knowledgeable. Our goal is to help you focus your efforts into the areas where small improvements will make a big difference in compliance.
CAPA initiation / implementation
Corrective Actions and Preventive Actions (CAPA's) help also help focus your efforts in an organized manner. We will work with you to identify a problem's Root Cause, remediation plan, correction implementation, and effectiveness evaluation. We will also help you document quality improvement actions as Preventive Actions, a point that is often missed when a company could be taking credit for its preemptive actions to address potential risks to quality.
Complaints are the best opportunity to detect potential problems early, before they snowball into big problems. Complaints are not necessarily bad. Ignoring them is. We can help set up an effective complaint system to capture, investigate, correct if necessary, and document the process. Again, this is a key requirement for a quality system but it is also a great opportunity to succeed.
Medical Device Reporting
All complaints should be reviewed for Medical Device Reporting to the FDA or Vigilance Reporting to your a competent authority through authorized representative. Most likely the complaint is not serious enough to require reporting but the justification for nor reporting must be documented. We can help write an effective procedure and implement incident reporting where necessary.