MARACA International BVBA in Rotselaar, international consulting in medical, clinical and regulatory affairs

At MARACA International BVBA in Rotselaar provides regulatory and clinical services to manufacturers of in vitro diagnostic and medical devices, pharma companies, notified bodies and clinical laboratories. As a part of their service they provide CE marketing which would give conforming products the CE mark label. They provide assistance to manufacturers to obtain the FDA registration. In their clinical evaluation they assist with quality systems in compliance with applicable standards and regulations. Another important part of product development in clinical studies is risk management. MARACA International BVBA can provide a systematic performance evaluation. The professionals also gives companies e-learning training, such as IVDR training.

Services at MARACA International BVBA 

MARACA International BVBA can offer a complete or partial clinical research service. The professionals can also assist in managing a part of or your complete regulatory department activities. MARACA International BVBA offers a complete list of services to assist the manufacturer in obtaining the CE mark for their products. The team has more than 20 years of experience in the field of clinical studies and clinical evaluation and can thus provide you with excellent services including:

• FDA registration
• CE Marketing
• Performance evaluation
• E-learning training

Registration and quality systems

Medical devices or in vitro diagnostic devices that are placed on the European market, must meet the requirements of their respective Directives or Regulations. Products that comply with these directives and regulations receive the CE mark label. MARACA International BVBA assists manufacturers in receiving this mark by for instance providing hands-on training or the management of incidents. They also assist manufacturers in obtaining FDA clearance or registration for their products. The services for FDA registration include a review of the technical documentation and interactions with the FDA. To help you with your quality systems they can guide you to what is needed for a quality system in accordance with applicable standards and regulations. This service can include a gap analysis audit, writing of documents and development of templates. 

Risk management and training sessions

The US Device regulations and the China Device regulations require risk management in the product development process to distribute products in their territories. MARACA International BVBA in Rotselaar will also help you with a risk management file which is well-structured, cohesive and in compliance with regulatory requirements. With training sessions provided by these professionals you will ensure that you and your employees continue to have a competitive edge in the field and are well-educated on the changing regulations and standards. 

Feel free to contact us if you have any further questions or to make an appointment. You can also leave a message with the contact form.