ANALISA DAN RANCANG BANGUN TEMPAT TIDUR BAYI ( BABY COT )

Abstrak

The success of the national health insurance program (JKN) requires certainty of the availability of drug
supplies and medical devices from local industries. The limitation of the local medical device industry is an
obstacle to the success of the program, and then released national program to accelerate the development of
the independence of the national medical device industry. This research is intended to find an alternative
way to accelerate the development of the medical device industry by developing upstream technology,
namely product design and development. With this technology, an effective way of developing medical device
products for small industries will be obtained, the product reaches the market immediately, and meets
regulatory requirements. The product used in this case is a baby cot. The product development model used is
to follow the regulatory requirements for good medical devices manufacturing practices (CPAKB), SNI ISO
13485 and a systematic approach to design a product that is safe, and effective as intended use. Information
on product requirements and test methods is taken from EN 1130 Part 1 and Part 2. Using a systematic
approach the requirements and functions for the product can be analyzed. Furthermore, the embodiment
design and detailed design are developed. The correctness of the design is proven by making functional
prototypes and verified by the stipulated design requirements. From this research, it was found a way to
develop medical device products for baby box products that are safe, and effective as intended use meet
regulatory requirements.