Qultek Consultants Inc Information

EU MDR/IVD & ISO 13485:2016 Subject Matter Expert (SME) Audit Services EU MDR Audit/Assessment, ISO 13485:2016 Audit, MDSAP Audit and External/Internal audits EU MDR Gap Audit/Analysis An MDR Gap Analysis is your organization’s first step towards achieving maximum compliance with the EU MDR. Four (4) days EU MDR Gap Analyses will provide the following: • Your team will know precisely which areas your organization needs to revise in accordance with the new MDR. • Gap Analysis will examine the status of your company’s QMS and EU MDR procedures and technical documentations. • A thorough gap analysis will offer strategic and upcoming clinical activities. • Gap analysis will help best fit your needs. • After the Gap analysis we can put together a plan that will mitigate all the regulatory gaps found in analysis. EU MDR Subject Matter Expert (SME): • Post-Market Surveillance (PMS) • Technical Documentation • PSUR and PMCF • PRRC Services • Labeling and Transparency, and UDI • Clinical Evaluation • Material Of Concerns (MoC) • EU MDR Training Help small and startup medical device manufactures to minimizes budget constraints.