Markt Strategy
drs helps you to set up an effective plan for market introductions, because we describe the optimal strategy for your product clearly and incrementally, to meet regulatory and clinical testing.
Clinical Strategy
drs helps you sett up and implement a clinical strategy for your product. We take care of one or more of the following steps for you.
- The validation of product properties. Is it necessary to carry out clinical trials for each property? Or can existing research or scientific publications be used?
- Control. Does the documentation of the clinical study meet all relevant laws and regulations?
- The entire process of approval by authorities.
- The selection of institutions that carry out clinical research.
- Writing and editing clinical evidence.
International product-registration
From the beginning of the 90s drs has gained extensive experience in interacting with authorities in the EU, USA, Canada and the Far East. That allows us to get your product onto a new market as soon as possible. Our services for product registration:
- The preliminary discussions with the regulatory agencies.
- The assessment of the project documentation.
- The composition, application and support of your file by institutes all the way to a final approval.
Product development
drs helps you get a clear picture of standards you should consider when developing new products. drs helps you identify them … plus, we tell you how you should interpret them.
Audits
drs supports you in the case of internal audits, in their preparation, supervision and follow-up audits by governments such as IGZ and regulatory agencies like Notified Bodies and FDA.
Training
drs teaches your employees how they can integrate regulations in their work. The training that we provide looks, besides theoretical aspects, in particular at the practical aspects. The courses cover the following areas:
- EU Medical Device Regulations.
- FDA Medical Device Regulations.
- Risk Management for Medical Devices.
- Medical Software.
- Clinical Evidence Medical Devices.
Post Market
Na overheidsgoedkeuring kan drs u helpen met het in stand houden van de status van uw product bij controles en veranderende wetgeving.
- Post Market Clinical Follow Up.
- Change Notifications bij de toelatende instanties.
- Vigilantie en MDR-rapporten bij overheden.
- Field Corrective Actions.
