Medical products travel across the world. Blood pressure monitors made in Asia are sold in Europe. Similarly, blood glucose monitors travel thousands of kilometers to reach buyers. How do buyers rely on products imported from a distant country? It is where ISO 13485 requirements help medical device manufacturers. Buyers invest only in ISO-certified products.
What are ISO standards for medical products industry?
ISO is entrusted with the task of regularizing the medical device industry which is expanding at a fast pace. Every day new manufacturers set up their facilities and start producing cheap medical devices. They don’t have any R&D centers to invent products. They simply copy the popular products in the market and launch cheap versions of popular products.
ISO 13485 requirements for the medical products industry are international standards of quality. Any medical device or machine that doesn’t fulfill the ISO standards is considered of inferior quality and unsafe. The manufacturer of unsafe medical products is penalized for making spurious devices and their facility is shut forever. However, ISO-certified businesses are allowed to flourish by targeting international markets.
What happens if you don’t have ISO 13485 certification?
The absence of ISO certification could cost you dearly both in terms of marketing and sales. First, you will need to be careful about regulatory compliances and keep an eye on new regulations. Second, you will need to obtain permission before adding a new product to your inventory or even making a minor change in the design or functionality of your products.
Fulfilling ISO 13485 requirements will change the scenario for your business. The certification will boost your regulatory compliance including new rules. ISO will keep your system updated with necessary changes so you don’t have to face the music for non-compliance. Also, you won’t have any difficulty in obtaining permission for new products.
How to get ISO certification?
ISO has a system of awarding certifications. The process starts with applying for a certificate like 13485 certification for medical device industry. The applicants are allowed to make necessary changes in their businesses. Later ISO audits the businesses and awards certificates on the basis of audit reports.
An experienced ISO consultant can help fulfill ISO 13485 requirements for certification. The requirements include simplifying the standards and implementing them in a business organization in letter and spirit. Also, the consultant will help pass the audit test. Consultancy will cost you a price but you will get certification in due time.