Jakarta
Ruko Citra Garden 6
Tegal Alur, Kalideres, Jakarta Barat
DKI Jakarta, Indonesia
Kuala Lumpur
1 Sentral, Level 16,
Jalan Stesen Sentral 5,
KL Sentral, Kuala Lumpur, 50470
Malaysia
Tel: +60 3 2787 9141
Copenhagen
PharmEng Nordic ApS
Fredericiagade 15,
København, Denmark
1310
Phone: +45 9389 1976
Barcelona
Calle Rossello, NUM 224
Planta 4, Puerta C
Barcelona, 08008 Spain
Puerto Rico
Caguas, Valle Tolima
INOVA Ave Innovación Lote 16,
Caguas, Valle Tolima, 00726
Tel: 787-344-1591
Pina, Recife
Av. Eng. Antonio de Goes, 60 Sala 702
Edf JCPM Trade Center 51.010-000
Tel: +55 81 4042 9049
Santo Domingo
Av. Winston Churchill, Torre Citi Acropolis, Piso 8
Email: info@pharmeng.com
Tel: +1-809-731-8123
Medical Device covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Classifications are based on their design complexity, their use characteristics, and their potential for harm if misused. Each country or region defines these categories in different ways.
Health authorities have heightened regulatory requirements to assess their safety, effectiveness, and quality before authorizing their sale in the markets.
PharmEng has extensive experiences dealing with the regulatory agencies. Whether the goal is to determine the substantial equivalence of your medical device, implement a quality management system that complies, or obtain approval for prior notification to markets, PharmEng will ensure your efforts comply with all regulatory requirements and standards around the world.
