We provide PMS & PMCF Services
MDR-compliant Post Market Surveillance from a single source.
If you need to subject your new or existing medical device to a clinical evaluation in order to (continue to) sell it on the market, you will be confronted with a number of questions.
What does post-market surveillance and vigilance mean for you as a manufacturer?
Post-market surveillance is the tracking of the medical device on the market throughout its life cycle. To prove the safety and performance of the medical device, the analysis and evaluation of customer complaints is no longer sufficient.
The legislator stipulates that a proactive examination of one’s own medical devices and those of competitors must be demonstrably carried out and appropriate measures initiated if the medical device no longer meets the state of the art in terms of safety and performance as well as the risk-benefit ratio. The PMS plan shows how this is to be done on a product-specific basis and which methods are to be used to achieve the declared goal of tracking.
How do you effectively use the PMS process for your business?
A structured approach is necessary to:
- Plan time and effort
- Plan resources
- Plan financial effort
- Define the clinical objective
- Understand potential risks of the planned interventions
It is important that both the passive collection of market data via customer complaints and the proactive measures of data analysis and data collection are coordinated to create as holistic a picture as possible of the safety and performance as well as residual risks and clinical utility of the medical device.
Already during the development of a medical device, you as a manufacturer should think about the planning of PMS activities, because often the costs and efforts of the medical device are underestimated after the initial marketing.
What are your obligations as a manufacturer?
With MDR 2017/745, the legislator has manifested that PMS activities are part of the manufacturer’s responsibility.
European legislation has clearly formulated how market tracking should be done and communicated requirements that both the methodology of tracking and the evaluation of results are done in accordance with the rules.
Every medical device must be included in the process of product tracking in the market. The effort required to do this depends on the risk of the product, as well as the preclinical and clinical data situation and the outcome of the risk assessment. These aspects must be included in the planning of post-market surveillance activities. Only when the methodology is documented on a risk basis can it be ensured that the effort for PMS activities is targeted and can be carried out efficiently.
How are PMS and quality and risk management related?
The manufacturer’s ISO 13485 quality management system must define how the manufacturer fulfills its responsibility to track its own medical devices after they have been placed on the market. Both passive complaint handling activities, which include the so-called vigilance system, and proactive follow-up through the manufacturer’s own research, clinical data and demonstrably continuous data collection play a major role.
The basis for these activities is risk management, which as an integral approach records and evaluates the risks of the product and helps to determine suitable measures to assess the product as safe and efficient over the entire life cycle.
Clinical claims
We shape the list of clinical claims and figure out the actual clinical claims and increase the success rate your device.
Relevant endpoints
The next step is to define proper parameter that will be tested in clinical trials. Should you choose the wrong claims and parameter for testing, the whole clinical trial is useless.
Guaranteed MDR Compliant
We make sure that your product is compliant with the existing standards and regulations.
What are the main challenges with the PMS and vigilance for medical devices?
The main challenge is to develop a good study protocol addressing 3 critical points.
Imagine hiring external support to tell you what needs to be done in the PMS process to keep your product in the market. You are then either busy guiding and managing other teams to help you with the PMS, or you and your team are completely consumed with executing the PMS plan yourself. In both cases, you are left with the work (and actually, you don’t have time for it).
We develop the PMS plan for your and implement every step of that plan. Instead of spending way too much time on project and team management, you can focus on the essentials of your business while we watch your back and take care of the PMS.
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Why should you as a manufacturer rely on external partners to conduct a PMS?
Today, the formal set-up of the methodology is still a hurdle for many manufacturers and it is unclear how much effort is required to set up PMS activities in compliance with the regulations. An independent third party view of the product, risk management and existing data helps to set up appropriate and necessary processes and methods to meet regulatory requirements.
If additional clinical data need to be collected, professional planning is the key to a successful study. In most cases, the rules of a clinical study must be followed, and the study must be set up correctly in terms of methodology and objectives. The know-how is not always available at the manufacturers, especially if the products have been marketed in the past through equivalence comparisons.
Hands-on Consultants
We are not consultants who stand by and just tell you what you should do differently. We pitch in so you can keep your focus on your business: Leave the study design, the technical documentation and also everything else to us we ensure the approval of your product.
Dr. Veit Otto
Dr. Otto has decades of experience in the management of medical technology companies, in some cases leading them to 8-digit sales and successfully accompanying them as CTO in development, regulatory affairs, QM and production.
Dr. Michaela Hajek
Dr. Michaela Hajek supports your company as an experienced management and technology expert. Her focus is on interface management and risk management-based, goal-oriented development and approval of medical devices.
Dr. Yuriy Lebed
Dr. Yuriy Lebed manages a team of experts in clinical research. His team delivers full support to eliminate any concerns about the quality of clinical data.
How do we conduct a post-market surveillance (PMS)?
Here is an infographic that illustrates our work and design process for a PMS. (Please note that this illustration is intended to provide a simplified view of the process. Individual steps are likely from project to project).
Do not hesitate to ask us how a PMS could look like for your project. Simply use our contact form for this purpose.