Regulatory1

Regulatory1

• 1.
  Regulatory1 is aMedical Device, IVD consulting company based in Bangalore. We are experts in Quality and Regulatory Compliance, Biocompatibility, Mechanical Testing, Preclinical, Clinical (investigations and documentation), Quality Systems,Auditing, and Training Support. Regulatory1 provides complete “One Stop Shopping” support for the Market Approval (MA) of Medical Devices and IVD’s.
• 2.
  Our experts areable to assist you at every stage of a quality compliance program for ISO 13485 and FDA. We provide a broad range of services designed to reduce the complexity and pressure of keeping your facilities and operations within compliance guidelines. We can assist in maintaining compliance with a variety of certifications such as ISO 13485. Regulatory1 :
• 3.
  When testing medicaldevices the importance of high precision and accuracy within your test results is crucial. Only by performing high quality testing in accordance to the relevant standards within medical device testing, can you be assured that your product lives up to the specific requirements, and that it does the job that it is designed for, in an approved and safe way. Medical Device Testing Mechanical testing Electrical Testing Packaging& Stability Testing Biocompatibility Testing Preclinical Testing Clinical testing
• 4.
  Medical Device Trainingas a part of the product development life cycle. Our medical devices courses allow you to have a detailed look at some of the most important sections of bringing a successful product to market within this highly regulated sector. CE marking training courses: 1. Regulatory requirementsfor MedicalDevice 2. Regulatory requirementsfor IVD ISO 13485 Courses : 1. Introductionto ISO 13485:2016 2. ISO 13485 InternalAudit training 3. ISO 13485 documentation andImplementation REACHTraining RegulatoryAffairsTrainingfor Medical Device CE marking 510(K) documentation and submission Indian RegulatoryRequirementsand documentation
• 5.
  Medical devices thathave direct or indirect contact with the body tissue is an important quality issue relating to the biocompatibility of the product We provide testing services that are cost-effective, quickly performed, reliable and furnish data results. 1.Cytotoxicity (Tissue Culture) 2.Sensitization Assays 3.Irritation Tests 4.Acute Systemic Toxicity 5.Subchronic Toxicity 6.Genotoxicity 7.ImplantationTests 8.Hemocompatibility 9.Carcinogenesis Bioassay 10.Reproductive And Developmental Toxicity 11.Preclinical Safety Testing 12.HistopathologyServices
• 6.
  Ethylene oxide isnormally chosen because it is effective and will not adversely affect the materials used to manufacture medical devices. Ethylene Oxide (EtO) is known to exhibit a number of biological effects which include irritation, organ damage, mutagenicity and carcinogenicity in human and animals, and reproductive effects in animals. We provide testing services that are cost- effective, quickly performed, reliable and furnish data results.
• 7.
  Regulatory1 : An independent,third party laboratory, testing laboratory provides medical device package validation testing to ISO 11607. Regulatory1 supports you with the Package strength testing and package integrity testing to evaluate the packaging after such exposure. • Seal Strength • Dye Penetration • Bubble emission • Burst testing • Tensile Properties • Impact resistance • Accelerated Aging of Sterile BarrierSystems • Tear Resistance
• 8.
  Regulatory1 can performmechanical testing as an independent analysis and can ensure you meet the most demanding test requirement in the industry in accordance with FDA, ASTM, CE and ISO guidelines. As per ASTM Standard: • Tensile Impact and strength • Sheer Strength • Fatigue or Bend • Peel Strength • Material Characterization • Corrosion,Impact, Flammability • Hardness Testing • CompressionTesting
• 9.
  The complexities ofdevice are coupled with presence of power factors in most medical devices. In order to comply with all safety requirements, compliance to which ensures delivery of right technology in the right way. A means to verify the devices againstthis desired compliance is testing. Regulatory1 can support to get the safety testing for electrical and electronic devices that deal with electrical power and electromagnetic interference have a common set of prescribed tests and standards. As per Standard: • IEC 60601- 1 Compliance testing • IEC/EN 60601-2-37: Ultrasonic Diagnostic and MonitoringDevice • IEC/EN 60601-1-2: Electromagnetic compatibility (EMC) • IEC/EN 60601-2-19: Baby Incubators • IEC/EN 61010-1-101. Electro Magnetic Compatibility for IVD • IEC/EN 61326
• 10.
  Regulatory1 : Preclinical testingencompasses testing of all materials and prototypical devices prior to testing or use in humans. This testing is generally conducted in order to provide a reasonable assurance of device safety prior to use in humans in a clinical trial. As per ISO Standard: • Implantation Study • Feasibility study • Biocompatibilityof final device • Acute Studies and Chronic Studies • in vitro and in vivo biocompatibility/ toxicity testing, • Ex vivo device testing, • In vivo feasibility testing,and in vivo testing for safety
• 11.
  Regulatory1 : For medicaldevices, good engineering does not guarantee clinical trial or commercial success. Executing a successful market strategy involves navigating the Regulatory approval process, designing and conducting efficient clinical trials, and adeptly evaluating the existing marketplace. Regulatory1 can support with Pilot Study and Pivotal Study and also pharmacovigilance based on the client requirement.
• 12.
  Regulatory Affairs Regulatory1 isable to provide a full spectrum of consulting services for obtaining medical device approval in India, EU and US. Our consulting team works directly with the CDSCO on an ongoing basis for regulatory submissionsin India. As per Regulatory Requirement: • Identifying device classificationand Regulatory Standards • Regulatory Consultationand Strategy • CE Technical File • DesignDossier • DHF and DMR • Product Developmentdocumentationat all phases • Risk ManagementFile • Product Labeling • Clinical Evaluation Report
• 13.
  Regulations can bean overwhelming hurdle when moving your product through the medical device industry. That’s where Regulatory1 comes in. We’ve designed our business to provide the right amount of support at the right time —helping clients through all the important and difficult parts of bringing a product to market and staying compliant. • Regulatory Submission • EU technical files, CE marking, 510(K) submission • Clinicalevaluationreports (CER) • STED Support • Regulatory Strategy • GAP assessment for existing documents • Regulatory strategy & Project deliverables • Due Diligence • EU MDR/IVDR Support • Design dossiers and Renewals • Change in Notified Bodies • OverallEU MDR/IVDR compliance strategy • Labeling review and Update