Rocky Scientific Consultation provides Assistance For The Company Which need to be certified with Good Distribution Practice For Medical Device (GDPMD), ISO 13485 : 2003 and also Medical Device Registration Assistance in Malaysia in a very competitive cost.
As of 1st July, 2013, the Medical Devices Act 2013 (Act 737) was enforce, thus requiring all local authorized representatives (LAR) or any parties involved with import, wholesale, warehousing or distribution of medical devices to obtain an establishment license as required by the Malaysia Medical Device Authority before being able to trade medical devices in Malaysia.
Rocky Consulting employs proven methods for Good Distribution Practice For Medical Device ( GDPMD) consulting and ISO consulting with razor sharp focus that is designed and implemented for success. The standard process is customized to your company, your culture and your industry. The process takes advantage of disciplined project planning and timeline management. Based on years of experience in management consulting, this process will help your new quality management system implementation and continual improvement programs show progress and achieve results faster and easier.
Rocky Scientific senior technical advisors is well established with deeper understanding on Medical Device Registration and has a vast experience with :
* Partner search and selection and also Local Authorized Representation for the principals which have multiple distributors in Malaysia.
* Preparation for CSDT Dossier template and Technical file For Notified Body audits, including mock inspections / audits.
* Regulatory documentation to comply with The Malaysia Medical Device Act 737
For small Companies which operates from the House please get in touch with us and we will assist you in getting your company to Comply with The Medical device registration . And we have many packages to be offered ti suit your budget for this certification activity.