Be one step ahead with us
Are you the manufacturer
and need regulatory support for the introduction of medical devices
to EU market?
We will provide the necessary documentation for placing the medical device on the EU market. We provide complete support in the preparation of technical documentation. Before the audit of the notified body we carry out preventive revision of the technical documentation. We provide pre-clinical and clinical evaluation, including the implementation of quality management system to the required extent. We are able to prepare technical and clinical documentation on a turnkey basis, only on the basis of design and development outputs.
We deal with the agenda of borderline products and the classification of medical devices. If you are considering launching a cosmetic product, food supplement, or personal protective equipment, we will guide you through the legislative process and ensure faster market entry. I want to make a request.
Need help keeping the device on the EU market in MDR and IVDR conditions?
The newly adopted European regulation of medical devices, Regulation (EU) 2017/745 on medical devices, commonly referred to as "MDR", and Regulation (EU) 2017/746 on in vitro devices, referred to as "IVDR", represent a revolutionary change in claims for manufacturers .
According to the experience with our customers, the most important changes are perceived in the area of demands on clinical data to justify the intended purpose, target groups and residual risks, demands on the quality management system, especially for clean room production with subsequent sterilization. A completely new agenda is created by the Periodic Safety Report of the Medical Device under Article 86 of the MDR, which needs to be updated regularly, even for Class IIb and III devices every year.
If you need help moving to MDR or IVDR, please contact us as soon as possible. The countdown timer runs uncompromisingly. I want to make a request.
Are you updating the clinical trial? Are you planning a clinical trial?
We will prepare updates of clinical trials, propose a follow-up follow-up plan and follow-up based on newly acquired clinical data.
The most common errors when updating clinical trials:
historically incorrect choice of equivalent medical device,
poor resource management methodology that does not meet MEDDEV 2.7 / 1 rev. 4.,
general lack of clinical data,
insufficient collection of clinical data from PMS,
failure to perform the necessary PMCF studies.
In some cases, equivalence clinical trials are not possible. This is the case with manufacturers of unique innovative medical devices or manufacturers of 'me too' devices who, for various reasons, do not have enough clinical data for a clinical trial. In this case, we can provide a draft plan clinical trials and complete administrative and organizational support to its approval by the Ethics Committee and the State Institute for Drug Control. I want to make a request.
Need to get reimbursement from public health insurance for your device?
We will help you specify what kind of the regulation effects your medical device (e.g. a device prescribed for an outpatient voucher or a ZUM device). We will prepare the supporting documents for reaching the maximum payment. We solve innovative medical devices for which there is not yet adequate performance.
The other two groups of medical devices are consumables and instrumentation. There is no direct reimbursement for devices, but for so-called large technology it is necessary to go through a specific approval process, which will allow subsequent contracting of related services by health insurance companies. If the medical device is in the so-called _ consumable mode , its price should be part of the calculation of the reimbursement for medical performance. But what if it isn't?
Are you at risk of regulatory scrutiny
and need to prepare for it?
Inspection from the State Institute for Drug Control may pose a threat to business results or product portfolio. We will prepare your company for regulatory scrutiny. When it comes to the announced control, many things can still be corrected, there is no hesitation and work in time.
We recommend all manufacturers and other economic operators in the field of medical devices to carry out a preventive audit - a simulated inspection. In such a “clean spot inspection” we assess the readiness for inspection and, in particular, compliance with all relevant legal requirements. Preventive preparation is usually 20 times cheaper than all direct and indirect costs incurred by the supervisory authority's inspection. I want to make a request.
Do you need a
legislative monitoring to ensure that you do not miss anything?
For our clients we provide permanent information and regulatory monitoring focused on both the Czech Republic and the EU. Expert analysis to create existing and pending legislation. We also prepare educational analyzes of administrative decisions and court case law. If necessary, we arrange legal services of a renowned partner law firm.
Each medical device manufacturer must maintain a quality management system (QMS) in accordance with applicable regulatory requirements. The QMS Management Representative must raise the organization's awareness of the applicable regulatory requirements. Frequently asked by auditors: “How do you monitor and evaluate changes in legislative requirements?” Our legislative monitoring can be the solution for you. Every month we bring news in the field of legislation and executive commented for manufacturers and distributors of medical devices.
The complexity of the regulation of medical devices sometimes requires professional consultation with the regulator. We provide documents for our clients to request opinions or decisions regarding the qualification or classification of medical devices. The better the request for opinion is processed, the more likely it is to achieve the expected result. I want to make a request.