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Certificates

WillCo Wells B.V. logo met 'Beyond Vision'

 

CERTIFCATES

Molding of our products, our Vendors/Suppliers, our own 'Manufacturing, Administration, Packaging and Sterilisation', is of the highest
quality and operates under the following Certifications:
(Some certificates, we did not yet receive)

Molding:

Medica Europe B
.V., located in Ommen, the Netherlands.
'Medica Europe' takes care of molding the ring and the lid, of our WillCo-dish® polystyrene (sometimes polycarbonate) dishes in
transparent, as well as in black.

Certified:  
ISO 13485 Production of Medical Devices.
ISO Class VII :  Clean room.


Manufacturing:


Noorderkwartier N.V., located in Schagen (NH), the Netherlands.
We have our production, all labelling and packaging of the WillCo-dish® Glass Bottom dishes, outsourced in full, at Noorderkwartier N.V.
For the past sixteen years Noorderkwartier N.V. took very good care of manufacturing and packaging, of our various types of WillCo-dish®
products.
To assure we manufacture an identical glass bottom dish, each and every time, we have our 'clean room manufacturing' fully robotised.

Certified:  
ISO 13485:2003 :   Production of Medical Devices.                                                                         
ISO Class VII :   Clean room and Heat-seal machines.
ISO 9000:2000 :   Administration.


Fine Machining and Tooling:

Observator Precisietechniek B
.V. located in Amsterdam, manufactures our various types of Assembly Devices, tools to
'Accurately/precise, Easy, Safe
and Quick', assemble our WillCo-dish®KIT dishes.

Certified  
Integrated Quality Control :    lSO 9001:2008                                                                                                      






Packaging
:

1.:   Nelipak Corporation (Nelipak® Healthcare Packaging), located in Venray, the Netherlands.
       Owner (Since 13 November 2013):   Mason Wells Buyout  Fund III, LP – U.S.A. (Previous owner:  Sealed Air Corporation,
       Elmwood Park, NJ, U.S.A.). 'Nelipak’, is our long term supplier of the ‘Rigid Medical Packaging’, the transparent ‘PET-G MED BLUE
       packaging material’, as well as the Tyvek® (DuPont) covers, for our ‘Blister-Pack - Single unit’ packed glass bottom dishes.

Certified:  
ISO Class VII      :   Clean rooms.
ISO Class VII :   'Nelipak' Heat-seal machines.                                                                           


2.:   SteriPack, Ltd., located (Head Quarters) in Clara, Ireland.
       SteriPack, Ltd., is our long term supplier of the ‘PA/PE and Tyvek® (DuPont)’ sleeves, for our ‘Pouch-Pack’, multi-unit packed (20 per
       sleeve and 200 per case) glass bottom dishes.

Certified:                           
ISO-11607- Part 1 :   Materials and Test methods.                                                                                       
ISO-11607- Part 2 :   Pouching machines.               
ISO 13485:2012    :   Quality Management System.
ISO/IEC17025 :   SteriPack Laboratory, Ltd. – Testing Laboratory.                                                                  

 

 

 
 

 

3.:  DS Smith Packaging Nederland B.V., in Eerbeek, the Netherlands (Head Quarters:  Rugby, United
Kingdom).
      DS Smith’ is our long term supplier, of all 'Blister-Pack / single unit' packed, solid ‘export carton’ packaging.

Certified:  
   
   


4.:  Rajapak B.V., locate
d in Breda, the Netherlands.

      Rajapak B.V., is our long term supplier of the Export-packaging, for the'Pouch-Pack / Multi-unit' packed dishes.

Certified:  
ISO 9000  Administration
ISO 14001  Environmental Management System


Sterilization
:


Synergy Health Ede B
.V., located in Ede, the Netherlands.

Synergy Health Ede B.V. (Former: Isotron Nederland B.V.) takes care of the Gamma irradiation, of all our WillCo-dish® Glass Bottom dishes.
Minimum dose of irradiation:  10 kGy. This treatment guarantees, because of the use of our high standard packaging products, that all our
WillCo-dish® Glass Bottom Dishes are STERILE R, for a period of five years.

Certified:  
ISO 13485:2003 :  Quality Management System.
EN 552 :  The provisions of a contract irradiation service.
EN ISO 11137-1:2006 :  The provisions of a contract irradiation service.
EN 550 :  The provisions of a contract ethylene oxide processing service.
EN ISO 11135-1:2007 :  The provisions of a contract ethylene oxide processing service.

Provisions of a laboratoty testing service associated with irradiation processing.
Provisions of a chemical and microbiological laboratory testing
service.


Supplier of Glass coverslips:   
Thermo Fisher Scientific (Former: Menzel Gläser GmbH.), in Braunschweig, Germany.

Thermo Fisher Scientific (Menzel) is our long term supplier, for borosilicate (German) glass coverslips, type D 263 M.
We order both standard glass, as well as 'specially selected' glass, to be able to supply various 'glass thicknesses', as well as a
'surface flatness' (ar), according to the highest standards.


Certified:
We are waiting for a response from our Vendor.
.......


__________________________________________________________________________

PLEASE NOTE: Because our 'Independent Quality Control Laboratory" EggCentris in Belgium changed their activities, we are in the
process of establishing a new relationship, with a QC Laboratory in Barcelona, Spain.
As soon as we have new certificates, we will post them, below.

Fertility & Infertility
:     Certificates                                                                                                       
IVF test :     Open certificate
Sperm test :     Open certificate
MEA test :     Open certificate
LAL test :     Open certificate                                                                                                    









____________________________________________________________________________


"ISO 13485" explained:
(ISO 13485 explained, in an Abstract, from: ISO - International Organization of Standardization).
"ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability
to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable
to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management
systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001
that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems
conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the
requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the
organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for
their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed
in the quality management system.
It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and
development controls. If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical
device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its
quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the
organization, are the responsibility of the organization and are accounted for in the organization's quality management system."


 

 

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