Inspiry Thinks
Inpsiry assists you in obtaining company certification, company permit, product registration, and hospital or clinic license that is in line with government regulations and directly increases company credibility.
License Holding
License holding will act as the official license holder for a device, assisting in obtaining and maintaining regulatory approvals and compliance with local regulations, especially for companies who wants to market their product in regions without a physical presence.
What You Will Get:
Regulatory Consultation
We are familiar with the legal specifications that are frequently involved in license holding services. We help the manufacturer navigate the regulatory process and keep up with any changes to the laws.
Submission and Approval
We help our clients for their product to be approved by the regulatory bodies by helping to prepare and submit it. This entails gathering clinical data, technological files, and other necessary information.
Interaction with the Authorities in Charge of Regulation
On behalf of the manufacturer, the license holder serves as the main point of contact with regulatory bodies. They deal with correspondence, questions, and any updates or changes that should be made to the regulatory submissions.
What is the benefit:
- Low investment
- Simple Procedure
- Flexibility
- Faster Market Entry
International Standard License
ISO Certification
ISO 9001 - 2015
QUALITY MANAGEMENT SYSTEM
In order to increase customer trust and satisfaction, as well as motivate employees and create a culture of continuous improvement and improve product and process quality assurance.
ISO 37001 - 2016
ANTI-BRIBERY MANAGEMENT SYSTEMS (ABMS)
Assist organizations in implementing an anti-bribery management system and provide assurance to management, organization owners, shareholders, customers, and other business partners.
ISO 45001 - 2018
OCCUPATIONAL HEALTH AND SAFETY
Able to reduce the number of workplace accidents as well as take into account the risks and hazards so as to strive for continuous improvement. Also, there are legal and other requirements related to the OSH management system.
ISO 22000 - 2018
FOOD SAFETY QUALITY MANAGEMENT SYSTEM
Demonstrate a real commitment to global food safety that ensures proper consumption of food and beverages so as to gain the trust of national & international customers.
ISO 14001 - 2018
ENVIRONMENTAL MANAGEMENT SYSTEM
Helps save costs in handling waste and reduces negative impacts on the environment due to operational activities such as waste pollution and efficiency of energy resources. This will improve the company's image from a public perspective and strengthen relations with regulators, investors, and potential creditors.
ISO 13485 - 2016
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEM
An organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer needs and applicable regulatory requirements. This includes the design and development, manufacture, storage and distribution, installation, or servicing of medical devices.
ISO 17025 - 2017
MAIN STANDARD FOR TESTING AND CALIBRATION LABORATORIES MANAGEMENT SYSTEM
Useful for doing tests, sampling or calibration, and want reliable results. This includes all types of laboratories, whether owned and operated by the government, industry, or other organizations.
ISO 11135 - 2014
STERILIZATION OF HEALTH-CARE PRODUCTS
Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and healthcare facility settings.
ISO 14971 - 2015
Medical Devices - Application Of Risk Management To Medical Devices
To set a process for manufacturers to identify the hazards associated with medical devices, including in vitro diagnostic medical devices (IVD), to estimate and evaluate the risks to those products, to control these risks, and to monitor the effectiveness of controls.
ISO 27001 - 2013
Information Security Management System
Determine the requirements for establishing, implementing, maintaining, and continuously improving an information security management system within an organizational context.
Quality Improvement Program
for Hospital
Quality Improvement Program for Hospitals offers various certification and training services that enhance the capability and skills of management and all hospital personnel in supporting the quality and operation of the hospital,since it directly affects the effectiveness of operations, patient satisfaction, healthcare service quality, and overall facility success.
Training Registration FormISO Certification for Hospital
ISO Certification
ISO 9001 - 2015
QUALITY MANAGEMENT SYSTEM
ISO 11135 - 2014
STERILIZATION OF HEALTH-CARE PRODUCTS
ISO 45001 - 2018
OCCUPATIONAL HEALTH AND SAFETY
ISO 27001 - 2013
Information Security Management System
ISO 14001 - 2015
ENVIRONMENTAL MANAGEMENT SYSTEM
ISO 22000
FOOD SAFETY MANAGEMENT
ISO 37001 - 2016
ANTI-BRIBERY
ISO 13485 - 2022
Quality Assurance For Medical Laboratories
ISO 14971 - 2013
Risk Management Medical Devices
ISO 17025 - 2019
MAIN STANDARD FOR TESTING AND CALIBRATION LABORATORIES MANAGEMENT SYSTEM
Training Program for Hospital
- ISO AWARENESS TRAINING
- AWARENESS TRAINING FOR "KALIBRASI"
- AWARENESS TRAINING FOR "K3L"
- AWARENESS TRAINING "FINANCE – FINON" PROGRAM
- LOGISTIC MANAGEMENT TRAINING
- TRAINING FOR MARKETING
- LEADERSHIP TRAINING
- RISK MANAGEMENT TRAINING
Our Training Program Excellences
Modules Completely arranged & in accordance with the needs of the hospital
Trainers are professionals in the health sector
Each training is accompanied by appropriate case studies
An interactive & fun training atmosphere
Equipped with pre-test and post-test evaluations
