Manufacturer of medical devices - Import export

Pharmaceutical and Medical Translation Services by medical translators and medical practitioners with multilingual proficiency with years of experience. Medical Translators specializing in Allergology, Andrology, Anaesthesiology, Cardiology, Dentistry, Dermatology, Emergency medicine, Endocrinology, Family medicine, Gastroenterology, General surgery, Geriatrics, Gerontology, Haematology, Haematology, Infectious diseases, Immunology, Intensive care, medicine, Medical Device Manufacturing, Medical genetics, Nephrology, Neurosociology, Neurosurgery, Nuclear medicine, Obstetrics and gynaecology, Oncology, Ophthalmology, Oral and maxillofacial, Surgery, Orthopaedic surgery, Otolaryngology, Pathology, Paediatrics, Plastic surgery, Podiatry, Preventive medicine, Psychiatry, Pulmonology, Radiation therapy, Radiology, Rehabilitation medicine, Rheumatology, Serology, Sexual health, Sleep medicine, Sports medicine, Surgery, Toxicology, Transplantation medicine, Urology, Wilderness medicine.

The Hawo® HD 650 D/DE/DC EcoPak® is a top-tier medical continuous sealing machine designed for precision and efficiency in sterilisation packaging. This robust, versatile tool is essential for healthcare facilities, medical device manufacturers, and industries demanding secure, sterile packaging.Key features include continuous sealing for uninterrupted operation, adjustable temperature and speed for material adaptability, and dual/triple sealing options for enhanced protection. Its integrated cutting mechanism, compact design, and user-friendly interface streamline workflow. Built to meet stringent medical standards, the machine offers reliable performance, easy maintenance, and wide packaging compatibility.Energy-efficient EcoPak® models reduce costs without compromising power.Ideal for sterilising instruments, packaging pharmaceuticals, implantables, single-use items, and consumables, the HD 650 D/DE/DC EcoPak® safeguards product integrity and patient safety.

Hawo® HPL ISZ IVM 300/250/630mm Impulse Heat Sealer Spare Parts Kit Essential replacement components for optimal Hawo HPL ISZ IVM impulse heat sealer performance.This comprehensive kit includes heating elements, Teflon tapes, silicone seals, fuses, bushings, bearings, switches, micro-switches, and more. Designed for efficient and reliable sealing across various industries, including food, pharmaceutical, and medical device manufacturing. Compatible with Hawo HPL ISZ IVM models in 300mm, 250mm, and 630mm sealing widths.Minimises downtime, reduces maintenance costs, and ensures uninterrupted production.Easy-to-use with clearly labelled components.Invest in the longevity and efficiency of your sealing equipment with this indispensable spare parts kit.

Contact us for safe and secure European warehousing, fulfillment and distribution services for your medical, surgical, diagnostic and imaging devices and healthcare supplies. We are located in an important European Medtec area with various small, medium sized and big medical and pharmaceutical companies like Medtronic, Merit Medical, Abbott and Janssen Pharmaceutica. Since 2010 we already have various value added warehousing, logistic and distribution operations in place for various international medical device manufacturers and healthcare supplies distributors

Our experienced team has for years done documentation for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements. For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services:
 Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR Creating QM-Systems with procedural instructions and work instructions Technical Documentation Clinical evaluation Risk Management / Risk Analysis Essential Safety and Performance Requirements Validation of processes UDI-labeling Consulting for Regulatory Affairs Internal audits and external supplier audits Accompaniment and support with inspections by authorities and Audits by notified bodies Communication with authorities

Maxcert is offering EC Representative services for non EU medical devices manufacturers. Maxcert is authorized/ registered EC REP service provider and can manage your ECREP requirements better than others. We make sure that you are MDR ready! and well updated with the EU regulations for your medical devices. Maxcert’s team has expert knowledge to help you navigate through the complex regulatory challenges that the new EU MDR bring. We can assist you through out the entire process to ensure that you and your business are compliant with all of the EU MDR requirements. For more information, reach out to us at