Our Generic Consulting Services module mainly helps you on
- Compliance to National and International Regulatory Directives
Compliance to IEC 60601, IEC 60601-1-2, -3, -6, -8 standards and particular standards IEC 60601-2-XX
- Product Safety Marks/Certifications
- Product Compliance as per specific Standard Requirements
ISO 13485 QMS system
Scope of our generic consultancy service for compliance to National and International Regulatory Directive includes but not limited to Low Voltage Directive (LVD), Pressure Equipment Directive(PED), Electromagnetic Compatibility Directive (EMC), Machinery Directive (MD), Medical Device Directives (MDD), In Vitro Diagnostic Device Directive(IVDD); Restriction of Hazardous Substance Directive (RoHS), REACH, US CFRs (21CFR).
Our another major generic consultancy service offers the support to client for getting Product Safety Certification and/or Safety Marks for example CE, S, UL, FCC, CAS, GS, CCC, VDE etc. to name the few.
Apart from complete consultancy projects as stated earlier, we also can cater to specific consultancy needs of the client in Product Safety and/or Essential Performance Compliances as per specific national and international standards e.g. IEC 60601-1 series; IEC 60601-2-xx series; IEC 62336, IEC62304, ISO 14971, IEC 601010, CB Scheme, USFDA - 510K, ISI Standards, BIS Standards.
Through our Management System Certifications consultancy module we can support you on Management System Certification too! Though we offer consultancy services mainly for commonly referred Management System Certification for example ISO 9001, ISO 13485, ISO TS 14949 etc., our scope is not limited to that. We have a pool of professional expert associates from other domains to offer you unmatched consulting services for any other Management System.
While working with ReguMark rest assure that we as an organization are committed to deliver ‘exact’ solution to any kind of critical issues in your Regulatory Compliance Processes. This is possible only because of our core team drivers’ ‘deep and wide’ experience in certifying 150+ products and having experience of conducting hundreds of Product and Management System Certification audits worldwide on behalf of renowned notified bodies like LNE/G-Med, UL, TUV etc over more than 25 years.
The manufacturer who is preparing his product for Certification puts in all his energy and efforts to meet all the compliance requirements. But it is not always possible to verify the compliance on his own or through his internal processes. Sometimes the requirements are not understood, sometimes the facility is not available to test and verify, sometimes there could be some design limitations. Hence to free the manufacturer from all such uncertainties we offer Pre-Compliance &/or Full compliance Services including the testing at our own Group Test laboratory. The laboratory is accredited for ISO 17025 and undergoing continuous approval processes to get latest national and international recognitions.
Under this Service module we provide following service sub-modules –
- Identification of applicable regulatory requirements
- Product Safety Marks/Certifications
- Actual Product and Technical Documents review for Pre/Full Compliance
- Product Testing for Pre-Compliance as per identified standards and requirements
- Detailed reporting with Pre-compliance test results and recommendations
- Guidance on improvement or design changes if any, to advance the product for full compliance
- Testing for Full Compliance with authentic reports that can be accepted by many Notified Bodies
- Full-fledged Testing facility available for IEC 60601-1, -2 and other standard compliances
Our Technical Documentation Service module provides complete support to all the Technical Documentation requirements for any of the Regulatory Compliances and Product Certification Requirements.
- Client’s Document Reviews and Gap analysis for Compliance to specific regulatory requirements, QMS Systems, Standards etc.
- Technical file / design dossier architecture and modeling
- Support on preparing any specific section or specific content of Technical File such as support on drafting the Reports for Overall Compliance Conformity (Declaration of Conformity),Essential requirement check Lists,Risk Management, In House Compliance Test Reports
- Support on preparing Quality Manuals, Quality Policy, Quality Objectives, QMS processes, Quality Records / formats as per the standards requirements
- Support on preparing Exclusion justifications or Compliance statements
- Support on drafting agreements with OBL/OEM partners, outsourcing partners, critical part suppliers, Competent Authorities etc to comply with the standard requirements.
A unique manpower resource service
Usually understanding and implementing the regulatory requirements is easier than converting them into formal documents and records. Further it becomes more critical and laborious work. It becomes a tough job to write the documents that can easily convince the reviewer or auditors in their language. Through this unique “REGU-WRITERS” service we can provide you professional Technical Writing experts on request. These writers get the inputs from actual processes and functions being carried out in your company, structure them as to meet both – your operational convenience as well as to meet regulatory requirements, write the policies and procedures, generate the records, verify them and finalize as per standard requirements.
While being associated with these writers during the document generation, your designated personnel get first-hand knowledge so that they can carry it further for continuation without any hassle
This service is available for writing any kind of documents required for Regulatory Directive Compliances, Product Compliance Requirements, Quality management Documentation requirements.
Training is an integral part of our all other service modules that keeps your knowledge updated. However, we can offer formal training through customized training packages as per your specific requirements.
Our expert trainers / faculty are armed with learner-friendly knowledge delivery capabilities, core topic knowledge and advanced techniques to make you master in –
- Understanding/Interpretation and application of Regulatory Requirements.
- Interpretation and application of Specific Harmonized Standards Requirements
- Documentation Requirements
- Technical Product Reviews
- Auditing Concepts
- Internal Auditors training
- Lead Auditors Training
- Any other special training requested by you on specific topics related to Regulatory Compliances
Apart from other main Services we take up the Consultancy projects for other complementing regulatory requirements such as
Management System Certifications for
- Environmental Management : ISO 14001
- Green House Gases : ISO/GHG 14064
- Automotive QMS TS/ISO 14949
- Competency of Testing and Calibration Laboratories : ISO 17025
- Occupational Health & Safety Management System OHSAS/ISO 18001 series
- Food Safety Management FSMS/ISO 22000 series
- Information Security Management System : ISMS/ISO 27000 series
- Setting up in-house Test laboratory (Electrical, Electro-medical, Bio-compatibility, Food and Drugs), Clean rooms, Sterilization setups etc., and getting the accreditations for those facilities like NABL, NABH, GLP, GMP