Medical Device Approvals & Compliance
RegPak has full range consulting capabilities across the globe, including an all-inclusive medical device consulting service offering. Our medical device consulting capabilities include all regulatory, clinical and quality compliance aspects of device, diagnostic and combination product development. We have experience with medical devices across all classes and spanning a diverse range of indications and therapeutic areas. Our emphasis on science, coupled with the technical expertise of our medical device experts, allows us to effectively communicate with regulatory authorities in support of your product.
Clinical & Safety
Our services include
Authorized Representative (AR)
As an AR under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), our experts meticulously verify technical documentation and ensure the declaration of conformity is drafted in adherence with EU standards.
Quality Systems & Regulatory Compliance
RegPak’s Quality Systems specialists help design and prepare Quality Management Systems (QMS) and SOPs compliant with Medical Device Regulations (MDR) and international regulations, support clients through European Notified Body and FDA/ISO audits as well as assistance in resolution of compliance issues.