Kiwa quickly and effectively supports SanoMed with ISO 13485 certification
SanoMed Manufacturing BV produces cosmetics, wound care products and nutritional supplements. The Dutch company’s unique feature is the frequent use of natural ingredients such as honey and olive oil. But medical devices and products based on natural sources also have to comply with the applicable laws and regulations, so SanoMed turned to Kiwa for renewal of its ISO 13485 certification.
SanoMed was founded almost fifteen years ago. The owners had been active in developing and producing honey products for years and had researched the role that honey can play as a wound care agent. They even published a number of scientific studies on this topic worldwide. SanoMed has patents on many products and in 2007 the company also received European approval for medical devices.
Medical Devices Regulation
In May 2021 the European Medical Devices Directive (MDD) was replaced by the Medical Devices Regulation (MDR). In this, the EU sets stricter safety and quality requirements for medical devices and also expands their scope by adopting a broader definition of the term 'supplier'. SanoMed also had to upgrade its certification to the MDR and, during its search for an accredited certification partner, came across Kiwa.
Certification within one year
Soon after SanoMed had delivered the clinical evaluation to the specialists of Kiwa Italy, the audits of the rest of the technical documentation could be started. At the same time, Kiwa Netherlands checked SanoMed's entire ISO 13485 quality system and a number of 'on site' audits took place. In less than six months, both the entire quality system and all technical documentation of four products to be certified were approved and certified, after some minor adjustments. All in all, there was less than a year between the first contact and the issue of the certificates.
Kiwa's Denise IJsselstijn: 'At Kiwa we always strive to unburden our customers and make complex processes simple. Short lines of contact, flexibility and a wide range of services and schedules, this sets us apart from other certifiers. If Kiwa Netherlands cannot do it itself, we will arrange for specialists in another Kiwa country or a partner to fill it in. Kiwa is a one-stop shop. We understand the customer’s business and can respond to this with a extensive range of certifications, in-depth knowledge and tailor-made service.'
‘Quality as a must for us’
SanoMed appreciated the short lead through time and efficient cooperation with Kiwa Netherlands. ‘Our customers are all certified pharmaceutical companies that cannot afford to work with non-certified suppliers,’ says SanoMed CEO Jan Vandeputte. ‘We are a small company, but our quality efforts have earned us a lot of appreciation and trust from our global customers and the various governments we communicate with about the status of our quality system. In short: quality is an absolute must for us!'