ADHOCON™️

ADHOCON offers Contract Legal Manufacturer services for AI and software in healthcare, aiming for compliance in global markets. With over 50 years of experience, ISO certifications, and a presence in Germany, UK, and Dubai, ADHOCON streamlines product registration and compliance for medical devices, excluding implantables. They provide a lean QMS, handle technical documentation, regulatory challenges, and ensure quick market access, reducing cost and lead times. Their full-service approach allows clients to focus on product development and innovation. Adhoc online services With our ADHOCON database sourced from over 150 Audits (as Auditor and Auditee) we are able to provide you the best practices and experience of Notified Body, Authority and Industry interactions. QA & Regulatory - full usable QMS-on-demand implemented incl. training within 1 week (cGMP, ISO13485 & 9001. EU MDR, EUDRALEX, US 21CFR, MDSAP), audit preparation, CAPA, deviation, complaint, backlog reduction, Authority communication, worldwide MedDev registration, Lean6S QMS improvement, mock-up recall, mock-up unannounced audit, Risk Management acc. ISO14971 We are in addition EUDAMED registered Authorized Representative for EU and PRRC. Small businesses can book our PRRC service and non-EU medical device manufacturers our AR & PRRC combination service Special Services Penetration testing - social engineering Regulatory departments hold all IP protected documentation or all errors ever happened. Competitors seek to steal them. We test your departments for those attacks and train them on preventive measures. Expert Witness and Appraisals As registered Expert Witness we investigate and write appraisals for courts for all classes Medical Devices and IVDs. C-Suite support We offer M&A due dilligence (Regulatory) for pharma and Medical Devices and offer QA & RA Forensics on persons, products and companies Business Contingency Management acc. ISO22301 - be ready for ANY crisis