• "Regumark" - not just the Consultant.We support you fully as your close business partner. All the support is offered interactively so that your policy makers and executors become self-sufficient for long term continuation of Regulatory compliances in your organization.
• We focus on your close involvement to get the optimal solution that fits well not only into Compliance Requirement but also into your budgets without compromising on the Regulatory Requirements.
• Our expert team members’ experience is not limited to Quality and Regularity Compliance functions only. Additionally our team members hold versatile industry experience in all the core functions right from design, development and manufacturing to end customer support in respective industry domains. This helps us to understand the exact needs of respective functional process, their limitations or pitfalls and provide RIGHT solutions to you.
• We do not compel our client to select any specific competent authority. Client is free to select the competent authority of his choice. However, we can support client to select the competent authority if the client desires so.
• We are fully armed with ISO 17025 accredited full fledged own group Test Laboratory to offer you a ‘Complete Solution’.
Responsible for guiding ReguMark’s Compliance Assessment, Testing and Consulting teams for all the technical assessment activities e.g. Identification of applicable Regulatory compliance requirements, Risk Assessments, Technical Documentation, Pre-Compliance, Full Compliance etc. Personally involved in many critical reviews, assessments and trainings.
Being Engineering Graduates and Post Graduations in Managements our core team leader are academically sound to handle any technical, operational and project management processes effectively.Each core member possess about 30 years of overall experience in various domains.
The technical domain expertise can be listed as Design and Development in Embedded and Medical Electronics apart from automation and Power Electronics. The hands on experience ranges to Project Management, Design & development(Electrical, Electronics, Medical, Mechanical domains), Software development(Embedded Software/Firmware, Client-Server Software, Application Software), Compliance Testing as per various standards and Technological Training.
Few of experience credentials in Quality and Regulatory domain can be listed as Quality Management System Certification (ISO 13485, ISO 9001, ISO 27000, ISO 18000, ISO 22000, ISO 50000, CMMI etc), Product Compliances and Certification (CE, MDD/93/42/EEC, USFDA, CB Scheme, S Mark), Risk Management (ISO 14971), IEC Standards (IEC 60601 series Part 1 and 2, IEC 62304, IEC 62336), QMS Training and Patents and IP Protection.
The team that will guide you holds overall 400+ auditing hours to their credit for auditing various QMS and regulatory compliances in different capacities such as Internal Lead Auditor, Technical expert, TCF reviewer, Consultant etc. The members are recognized/empaneled auditors of well-known Certifying &/or Notified bodies like UL, TUV, LNE-GMed, etc. To keep themselves up to date they are is continuously undergoing the training through workshops, bridge programs and specialized training sessions.
Our competent Customer Support Team caters to all activities and your queries for all pre and post order activities right from initial interaction with the customer to the delivery of last deliverable and post delivery support requirements if any. Like core Technical Team our Customer Support leaders are also Engineering Graduates with Post graduation in Management. They bear a mix and match of expertise in various business functions right from design and development, production to delivery and installation; right from sales calling to after sales support. Like our other expert leaders our Customer Support team is also available at your Service at any point of time before, during and after the completion of projects handled by us.
Apart from our core Technical Team we are backed up by pool of Experts Associates from various other domains to cater your specialized requirements in any of Quality and Regulatory domains including technological support
Our complementing documentation support service is offered through competent Technical and Regulatory content Writing Experts. The technical/regulatory compliance documents prepared by our team are well accepted by well-known global regulatory authorities and proven to be the best one.