Turnkey Project Consultant
Regulatory Approvals and Certification
188金宝慱亚洲体育
188金宝搏网站靠谱吗Operon Strongist是一家医疗设备188金宝慱亚洲体育咨询公司，为医疗保健行业的各种制造商提供监管指导，以确保这些制造商的战略发展。我们通过提供交钥匙服务，系统实施，培训，许可，监管批准和认证来为客户提供服务。我们为客户提供定制的解决方案，以寻求建立世界级制造业的制造商。
我们的全球业务迎合了全球客户，包括向世界知名的医疗设备制造商提供小型初创企业。我们拥有一支专家团队，其知识与经验有助于他们处理小型和大型的客户。
Our Services
FDA 510 k Clearance
We are a Bunch of Regulatory Professionals & Experts in FDA 510 k clearance
188金宝搏优惠
谈到CDSCO医疗设备许可证进程时，沃林策略家使得冗长的过程变得简单而平滑。188金宝搏网站靠谱吗
医疗器械CE标记
We help you in the process of making a defined and comprehensive technical file with all product details required for CE marking.
ISO 13485顾问provides Guidance for medical device manufacturers for obtaining ISO 13485 certification Quality Management System
Combination Product approval from FDA. Drug Device Combination Products is the combination of two or more drugs and medical device. ISO 13485:2016
With the expertise in regulatory affairs and quality management systems, we monitor facilities…
Medical Device Design and Development
Medical Device Design and Development plays a vital role in making the medical device. This is the most important stage in the medical device development
21 cfr part 820 (QSR)
FDA 21 CFR Part 820 Quality System Regulation Consultant Services For Medical Device Manufacturers.
设计控制要求
US FDA 21 CFR 820.30 Design Control Requirements for medical device design. Design Control Guidance For Medical Device Manufacturers
Operon Strategist is an expert Medical Device manufacturing consultancy providing registration support for Medical Equipment manufacturing in India.
