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Certificates

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

 

CERTIFICATES

Molding of our products, our Vendors/Suppliers, our own 'Manufacturing, Administration, Packaging and Sterilisation',
the QC laboratory for MEA - and LAL-assays, they all are of the highest 'quality' and operating under the following
Certificates: (Some certificates, we did not yet receive).

Moulding

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                Clean room Production of Medical Devices


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' robotised.

Certified:  
EN ISO 13485:2003 :   Production of Medical Devices
ISO 9001:2008 :   Administration production Management System
WillCo-dish® products :   Assembly, commissioned by WillCo Wells B.V.


Fine Machining and Tooling
:

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

Certified  
Integrated Quality Control      :   ISO 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 ( IAF and MGMT. SYS. RvA C 589).

Certified:      By: DEKRA Certification B.V.
EN ISO 13485:2012
ISO 9001:2008

:    Scope: Design, production, assembly and sales of thermoformed products, lidding
     material and sealing equipment, including packaging validation services.
     Assembly and packaging of products for the medical, pharmaceutical and consumer
     market.

ISO Class VII :   Clean rooms.
ISO Class VII :   'Nelipak' Heat-seal machines.                                                                                            
Tyvek® (Dupont de Nemours)-Batch 10157/1 :   Certificate of Compliance - 08-13-2015.


2.:   SteriPack, Ltd., located (Head Quarters) in Clara, Ireland, 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-11607:2006- Part 1 & 2 :   Materials and Test methods & Pouching machines.
ISO 13485 2012 :   Quality Management System
ISO/IEC1702 :   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
(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 minimum period of five years.

Certified:  
ISO 13485:2003 Open Certificate
EN ISO 13485:2012 Open Certificate                                       
ISO 9001-2008 Open Certificate
ISO 14001:2004 Open Certificate

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.
.......


__________________________________________________________________________

WillCo Wells B.V. -  I.V.F. Certification:

PLEASE NOTE:  For all our 'Fertility & Sterility' tests we have established a relationship, with EmbryoTools S.L., well
                            respected QC Laboratory in Barcelona, Spain.

We have the certificates, of the 'Series GWST-5030' & 'Series GWST-5040' dishes, on line on our home page.
We also have the certificate of the 'Series GWST-5040' dish from the FREE SAMPLES PROGRAM, on line too.
You are most wellcome to download these results, for copies or prints.

Fertility & Infertility                          
:     I.V.F.-Certificates
@ GWST-5030  
Sterilization :     GWST-5030 dishes, with LOT# 1503-359/1.5-05
MEA test :     Open certificate for I.V.F. dish GWST-5040 with LOT# 1503-359/1.5-05
LAL-assay :     Open certificate for I.V.F. dish GWST-5040 with LOT# 1503-359/1.5-05
 @ GWST-5040  
Sterilization :     GWST-5040 dishes, with LOT# 1507-368/1.5-05
MEA test :     Open certificate for I.V.F. dish GWST-5040 with LOT# 1507-368/1.5-05
LAL-assay :     Open certificate for I.V.F. dish GWST-5040 with LOT# 1507-368/1.5-05
 @ GWST-5040 'samples'  
MEA test       Open certificate for I.V.F. - 'FREE WillCo-dish®SAMPLES' dishes, GWST-5040.









 




____________________________________________________________________________



"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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