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Application for Certification

Initial Certification

Scope expansion

Renewal of the existing certification

Notification of changes (According General Business Conditions clause 5.3)

With the signature by DQS Medizinprodukte GmbH, this application is considered as

C e r t i f i c a t i o n A g r e e m e n tbetween DQS Medizinprodukte GmbH

August-Schanz-Str. 2160433 Frankfurt am MainGermany- hereinafter called DQS MED -

and

Name and legal form of the company:      Contact person(title, first name, surname):      

Street and house number:      Country / ZIP Code / City / P.O. Box:      

Phone / Fax:      

e-mail:      

- hereinafter called applicant -

The applicant hereby applies for the conduction of the below-selected conformity assessment procedures by DQS MED:

1. ISO 13485:2003*ISO 13485:2003 (SCC)*EN ISO 13485:2012 + AC:2012**DIN EN ISO 13485:2012**ISO 13485:2016ISO 13485:2016 (SCC)EN ISO 13485:2016DIN EN ISO 13485:2016

for the scope:

     

2. Directive 93/42/EEC (provide additional information in Application for Product Certification)

3. ISO 13485:2003 under CMDCAS***ISO 13485:2016 under CMDCAS***

for the scope:

     

4. ISO 9001:2015 for the scope:

     

5. ISO 15378:2015****DIN EN ISO 15378:2016****

for the scope:

     

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Application for Certification

Particularities / remarks:

     

The certifications to ISO 13485 marked with “SCC” are conducted under the accreditation of the Standards Council of Canada (SCC). The certification to ISO 13485 under CMDCAS is conducted under the accreditation of the Standards Council of Canada (SCC) and the recogni -tion of Health Canada. All other certifications mentioned herein are conducted under the accreditation of Deutsche Akkreditierungsstelle (German Accreditation Body, DAkkS).

* An extension or initial certification according ISO 13485:2003 can only be requested for an audit date before the 31st October 2018.I am aware that a certificate according to ISO 13485:2003 has a maximum duration until the 28 th February 2019. In the course of a transition audit, a conversion of the certification to the ISO 13485:2016 can only be performed during the term of an existing ISO 13485:2003certificate.

** An extension or initial certification according to (DIN) EN ISO 13485:2012 can only be requested for an audit date before the 30 th Novem-ber 2018. I am aware that a certificate according (DIN) EN ISO 13485:2012 has a maximum duration until 31 th March 2019, as announced in the “European Journal”. In the course of a transition audit, a conversion of the certification to (DIN) EN ISO 13485:2016 can only be per-formed during the term of an existing (DIN) EN ISO 13485:2012 certificate.

*** The CMDCAS program is being discontinued on 31 December 2018. I am aware that a certificate to ISO 13485 under CMDCAS has a maximum validity until 31 December 2018. By 01 January 2019, Health Canada must be provided with an ISO 13485 under MDSAP certifi -cate in order to maintain medical device licences of class II, III or IV medical devices. A conversion of certification to ISO 13485 under MDSAP will require a two-stage initial audit.

**** The DIN EN ISO 15378:2016 has equal content compared with ISO 15378:2015 and refers still to the ISO 9001:2008.Hint: The new Version ISO 15378:2017 with reference to ISO 9001:2015 (The new Edition of DIN EN ISO 15378 „Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2017); English version EN ISO 15378:2017“) will be expected to be available in January 2018.

The documents mentioned in the following were in each case made available to the applicant in a valid version at the time of the application. These documents, which were supplied to the applicant will, when required by DQS MED be amended and come into effect respectively as the latest version. The documents mentioned herein, becomes an integral part of the certification agreement:

- General Business Condition of DQS MED- Assessment Service and Prices of DQS MED- Supplemental Business Conditions for certification within the scope of specific certification programs, if applicable:

o Supplemental Business Conditions of DQS MED applicable for certification to ISO 13485 under CMDCAS

Additions, amendment or subsidiary agreement to this agreement shall be submitted in writing. In the event of invalidity of a single provision in this agreement, the validity of the remaining provisions will not be in any way affected. The invalid provision will be substituted by a valid provision coming as close as possible to the original one.

The certification agreement - including all correlating information - is subject to confidentiality and is valid upon the date of signing by DQS MED up until the expiry of each respective certification, or the effective cancellation by one of the signing parties.

By signing this certification agreement, the applicant confirms that they have read and understood this certification agreement as well as the above-listed documents, and accepts this on a contractual basis. DQS MED conducts the assessment/s in accordance with the above selected procedures.

           City, date and company stamp City, date

Applicant’s legally binding signature Signature for DQS Medizinprodukte GmbH

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